Drug InteractionPhase 1NCT05334108
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport
A Phase 1 study testing Ecopipam, Cohort 1 Probe Substrate Cocktail and Cohort 2 Probe Substrate in people with Drug Interaction, run by Emalex Biosciences Inc. at 1 site in United States.
Trial summary
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Ecopipam, Cohort 1 Probe Substrate Cocktail and Cohort 2 Probe Substrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 26 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects or female subjects of non-childbearing potential
- ≥18 and <55 years of age at the time of consent
- BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
- Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
- Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
Who cannot join
- Personal or family History of significant medical illness
- Clinically significant abnormalities on screening tests/exams
- History of or significant risk of committing suicide
- Donation of plasma within 7 days prior to dosing
- Donation or significant loss of blood within 30 days prior to the first dosing
- Major surgery within 3 months or minor surgery within 1 month prior to admission
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- Use of prohibited prescription, over-the-counter medications or natural health products
- Alcohol-based products 24 hours prior to admission
- Female subjects who are currently pregnant or lactating
- Positive pregnancy test
- Use of tobacco or nicotine products within 3 months prior to Screening
- Significant alcohol consumption
- History of drug abuse within the previous 2 years, or a positive drug screen
- History of allergy to study medications
- Undergoing abrupt discontinuation of alcohol or sedatives
- Not suitable for study in the opinion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Repeat Titrated Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Read the detailed description
Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.
- Conditions
- Drug Interaction
- Being tested
- Ecopipam, Cohort 1 Probe Substrate Cocktail, Cohort 2 Probe Substrate, Cohort 3 Probe Substrate Cocktail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcopipamDrug
ecopipam HCl ~2mg/kg/day
Cohort 1 Probe Substrate CocktailCombination product
dextromethorphan, caffeine, omeprazole, and midazolam
Cohort 2 Probe SubstrateDrug
bupropion
Cohort 3 Probe Substrate CocktailCombination product
dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days
Cohort 1 Probe Substrate Cocktail given on 2 separate days:
* midazolam: 1 µg infused IV
* caffeine: 200 mg oral tablet
* omeprazole: two 20 mg oral tablets
* dextromethorphan: 1.6mL (containing ~10 mg) oral solution Receives: Drug: Ecopipam; Combination Product: Cohort 1 Probe Substrate Cocktail |
| Cohort 2 | Other | ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days
Cohort 2 Probe Substrate given on 2 separate days:
- bupropion: 100mg oral tablet Receives: Drug: Ecopipam; Drug: Cohort 2 Probe Substrate |
| Cohort 3 | Other | ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days
Cohort 3 Probe Substrate Cocktail given on 3 separate days:
* midazolam: 10 µg/mL given as 1mL oral solution.
* dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution
* rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution Receives: Drug: Ecopipam; Combination Product: Cohort 3 Probe Substrate Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Secondary outcomes (133)
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for dextromethorphan in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for dextromethorphan in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL for IV midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL for IV midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for oral midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for oral midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for pitavastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for pitavastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for atorvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for atorvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for bupropion in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for bupropion in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for caffeine in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for caffeine in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for omeprazole in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
CL/F for omeprazole in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for dextromethorphan in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for dextromethorphan in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V for IV midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V for IV midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for oral midazolam in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for oral midazolam in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for dabigatran in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for dabigatran in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for pitavastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for pitavastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for rosuvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for rosuvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for bupropion in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for bupropion in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for atorvastatin in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for atorvastatin in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for caffeine in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for caffeine in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for omeprazole in the presence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
V/F for omeprazole in the absence of ecopipam
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 22
Total concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Measured: Up to Day 18
Total concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Measured: Up to Day 18
Unconjugated concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Measured: Up to Day 18
Unconjugated concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Measured: Up to Day 18
Conjugated concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Measured: Up to Day 18
Conjugated concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 18
Measured: Up to Day 18
Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 14
Safety and tolerability as demonstrated by the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints
Measured: Up to Day 63
Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS)
Safety and tolerability measures will be recorded at the indicated timepoints
Measured: Up to Day 63
Number of participants requiring concomitant medications
Participants will be continuously monitored for the use of concomitant medications
Measured: Up to Day 63
AEs with relatedness associated with dextromethorphan
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with IV midazolam
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with oral midazolam
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with dabigatran
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with pitavastatin
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with rosuvastatin
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with atorvastatin
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with bupropion
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with caffeine
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with omeprazole
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
AEs with relatedness associated with ecopipam
Subjects will be continually monitored for adverse events
Measured: Up to Day 63
Absolute values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Absolute values of hematocrit (percent)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Absolute values of hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Absolute values of Red blood cell (RBC) count (M/mm3)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Absolute values of sodium, potassium, chloride (mmol/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Absolute values of magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Absolute values of albumin and total protein (g/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatinine phosphokinase (CPK), and creatinine (U/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Absolute values of urine specific gravity
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine pH
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine glucose
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine protein
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine blood
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine ketones
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine bilirubin and nitrite
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urobilinogen (Eu/dL)
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in hematocrit (percent)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/mm3)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in sodium, potassium, chloride (mmol/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in albumin and total protein (g/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK), and creatinine (U/L)
Blood samples will be collected for the assessment of clinical chemistry parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine specific gravity
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine pH
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine glucose
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine protein
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine blood
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine ketones
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine bilirubin and nitrite
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urobilinogen (Eu/dL)
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Change from Day -1 to Day of Discharge in urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters
Measured: Up to Day 26
Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)
Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured
Measured: Up to Day 26
Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds)
Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured
Measured: Up to Day 26
Absolute values of oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs
Measured: Up to Day 26
Change from pre-dose for the respective day in oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs
Measured: Up to Day 26
Absolute values of heart rate (beats/minute)
Heart rate will be assessed as part of vital signs
Measured: Up to Day 26
Change from pre-dose for the respective day in heart rate (beats/minute)
Heart rate will be assessed as part of vital signs
Measured: Up to Day 26
Absolute values of respiratory rate (breaths/minute)
Respiratory rate will be assessed as part of vital signs
Measured: Up to Day 26
Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Blood pressure will be assessed as part of vital signs
Measured: Up to Day 26
Change from pre-dose for the respective day in SBP and DBP (mmHG)
Blood pressure will be assessed as part of vital signs
Measured: Up to Day 26
Absolute values of mean corpuscular hemoglobin (MCH) (pg)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin (MCH) (pg)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Absolute values of mean corpuscular volume (MCV) (fL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day 1 to Day of Discharge of mean corpuscular volume (MCV) (fL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Absolute values of mean corpuscular hemoglobin concentration (MCHC) (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin concentration (MCHC) (g/dL)
Blood samples will be collected for the assessment of hematology parameters
Measured: Up to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start26 Apr 2022
- Primary completion1 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Nuventra, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334108
- Sponsor's protocol ID
- EBS-101-HV-104
- Status last verified
- Dec 2022
- First submitted
- 11 Apr 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Repeat Titrated Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05334108
- Acronym / sponsor ID
- EBS-101-HV-104
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc, Nuventra, Inc.
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
Detailed description
Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: Ecopipam, Combination Product: Cohort 1 Probe Substrate Cocktailecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 1 Probe Substrate Cocktail given on 2 separate days: * midazolam: 1 µg infused IV * caffeine: 200 mg oral tablet * omeprazole: two 20 mg oral tablets * dextromethorphan: 1.6mL (containing ~10 mg) oral solution |
| Cohort 2 | Other | Drug: Ecopipam, Drug: Cohort 2 Probe Substrateecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 2 Probe Substrate given on 2 separate days: - bupropion: 100mg oral tablet |
| Cohort 3 | Other | Drug: Ecopipam, Combination Product: Cohort 3 Probe Substrate Cocktailecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 3 Probe Substrate Cocktail given on 3 separate days: * midazolam: 10 µg/mL given as 1mL oral solution. * dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution * rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male subjects or female subjects of non-childbearing potential
- ≥18 and <55 years of age at the time of consent
- BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
- Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
- Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
Key exclusion criteria (16 listed)
- Personal or family History of significant medical illness
- Clinically significant abnormalities on screening tests/exams
- History of or significant risk of committing suicide
- Donation of plasma within 7 days prior to dosing
- Donation or significant loss of blood within 30 days prior to the first dosing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecopipamecopipam HCl ~2mg/kg/day | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Cohort 1 Probe Substrate Cocktaildextromethorphan, caffeine, omeprazole, and midazolam | Combination product | Cohort 1 |
| Cohort 2 Probe Substratebupropion | Drug | Cohort 2 |
| Cohort 3 Probe Substrate Cocktaildabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam | Combination product | Cohort 3 |
Primary outcome
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of dabigatran in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of dabigatran in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of dabigatran in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of dabigatran in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of dabigatran in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of dabigatran in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of dabigatran in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of dabigatran in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
133 secondary outcomes
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Time frame: Up to Day 22
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Time frame: Up to Day 22
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Time frame: Up to Day 22
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Time frame: Up to Day 22
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Time frame: Up to Day 22
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Time frame: Up to Day 22
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Time frame: Up to Day 22
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Time frame: Up to Day 22
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Time frame: Up to Day 22
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Time frame: Up to Day 22
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Time frame: Up to Day 22
CL/F for dextromethorphan in the presence of ecopipam
Time frame: Up to Day 22
CL/F for dextromethorphan in the absence of ecopipam
Time frame: Up to Day 22
CL for IV midazolam in the presence of ecopipam
Time frame: Up to Day 22
CL for IV midazolam in the absence of ecopipam
Time frame: Up to Day 22
CL/F for oral midazolam in the presence of ecopipam
Time frame: Up to Day 22
CL/F for oral midazolam in the absence of ecopipam
Time frame: Up to Day 22
CL/F for dabigatran in the presence of ecopipam
Time frame: Up to Day 22
CL/F for dabigatran in the absence of ecopipam
Time frame: Up to Day 22
CL/F for pitavastatin in the presence of ecopipam
Time frame: Up to Day 22
CL/F for pitavastatin in the absence of ecopipam
Time frame: Up to Day 22
CL/F for rosuvastatin in the presence of ecopipam
Time frame: Up to Day 22
CL/F for rosuvastatin in the absence of ecopipam
Time frame: Up to Day 22
CL/F for atorvastatin in the presence of ecopipam
Time frame: Up to Day 22
CL/F for atorvastatin in the absence of ecopipam
Time frame: Up to Day 22
CL/F for bupropion in the presence of ecopipam
Time frame: Up to Day 22
CL/F for bupropion in the absence of ecopipam
Time frame: Up to Day 22
CL/F for caffeine in the presence of ecopipam
Time frame: Up to Day 22
CL/F for caffeine in the absence of ecopipam
Time frame: Up to Day 22
CL/F for omeprazole in the presence of ecopipam
Time frame: Up to Day 22
CL/F for omeprazole in the absence of ecopipam
Time frame: Up to Day 22
V/F for dextromethorphan in the presence of ecopipam
Time frame: Up to Day 22
V/F for dextromethorphan in the absence of ecopipam
Time frame: Up to Day 22
V for IV midazolam in the presence of ecopipam
Time frame: Up to Day 22
V for IV midazolam in the absence of ecopipam
Time frame: Up to Day 22
V/F for oral midazolam in the presence of ecopipam
Time frame: Up to Day 22
V/F for oral midazolam in the absence of ecopipam
Time frame: Up to Day 22
V/F for dabigatran in the presence of ecopipam
Time frame: Up to Day 22
V/F for dabigatran in the absence of ecopipam
Time frame: Up to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ecopipam, Cohort 1 Probe Substrate Cocktail and Cohort 2 Probe Substrate in people with Drug Interaction, run by Emalex Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam (time frame: Up to Day 22). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.