HealthyPhase 1NCT04275115
Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects
A Phase 1 study testing Drug Cocktail, Foliglurax and midazolam iv in people with Healthy, run by H. Lundbeck A/S at 1 site in France.
Trial summary
The purpose of this study is to help determine which types of drugs that may interact with foliglurax Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Drug Cocktail, Foliglurax and midazolam iv
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2020to 3 Apr 2020
- 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
- Healthy men and women with a body mass index (BMI) of ≥ 18.5 and ≤ 30 kg/m2 and a minimum body weight of 60 kg for men and 50 kg for women.
- Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.
Who cannot join
- The subject has a regular intake of more than 500 mg of caffeine per day or impossibility to stop intake, on holidays for example, without headaches forcing to take caffeine again.
- Other in- and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, One-sequence Study to Investigate the Effects of Multiple Doses of Foliglurax on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Caffeine (CYP1A2), Montelukast (CYP2C8), and Midazolam (CYP3A4) in Healthy Subjects
The purpose of this study is to help determine which types of drugs that may interact with foliglurax
Read the detailed description
This study is designed to evaluate the PK of caffeine, montelukast and midazolam following multiple doses of foliglurax in healthy subjects. The study is divided into four periods:
- Period 1: investigation of the CYP450 probe substrates (caffeine, montelukast, midazolam) alone followed by a 2-day washout before start of Period 2.
- Period 2: administration of foliglurax for 7 days to reach steady state.
- Period 3: administration of the CYP450 probe substrates in combination with foliglurax followed by a 7-day washout before start of Period 4.
- Period 4: investigation of the effects of foliglurax on the PK of the CYP450 probe substrates following washout of foliglurax.
- Conditions
- Healthy
- Being tested
- Drug Cocktail, Foliglurax, midazolam iv
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug CocktailDrug
Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)
FoligluraxDrug
Foliglurax
midazolam ivDrug
Single intravenous (iv) dose of midazolam 0.025 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Foliglurax | Experimental | Foliglurax, iv midazolam and cocktail of CYP450 probe substrates Receives: Drug: Drug Cocktail; Drug: Foliglurax; Drug: midazolam iv |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area under the plasma concentration-time curve from zero to infinity for midazolam after iv administration and for all oral cocktail probe substrates
Measured: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Cmax
Maximum observed plasma concentration of midazolam after iv administration and for all oral cocktail probe substrates
Measured: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start10 Feb 2020
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- 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
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275115
- Sponsor's protocol ID
- 18337A
- Status last verified
- Apr 2020
- First submitted
- 17 Feb 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, One-sequence Study to Investigate the Effects of Multiple Doses of Foliglurax on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Caffeine (CYP1A2), Montelukast (CYP2C8), and Midazolam (CYP3A4) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04275115
- Acronym / sponsor ID
- 18337A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 19 Feb 2020 (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.
The purpose of this study is to help determine which types of drugs that may interact with foliglurax
Detailed description
This study is designed to evaluate the PK of caffeine, montelukast and midazolam following multiple doses of foliglurax in healthy subjects. The study is divided into four periods:
- Period 1: investigation of the CYP450 probe substrates (caffeine, montelukast, midazolam) alone followed by a 2-day washout before start of Period 2.
- Period 2: administration of foliglurax for 7 days to reach steady state.
- Period 3: administration of the CYP450 probe substrates in combination with foliglurax followed by a 7-day washout before start of Period 4.
- Period 4: investigation of the effects of foliglurax on the PK of the CYP450 probe substrates following washout of foliglurax.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foliglurax | Experimental | Drug: Drug Cocktail, Drug: Foliglurax, Drug: midazolam ivFoliglurax, iv midazolam and cocktail of CYP450 probe substrates |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women with a body mass index (BMI) of ≥ 18.5 and ≤ 30 kg/m2 and a minimum body weight of 60 kg for men and 50 kg for women.
- Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.
Key exclusion criteria (2 listed)
- The subject has a regular intake of more than 500 mg of caffeine per day or impossibility to stop intake, on holidays for example, without headaches forcing to take caffeine again.
- Other in- and exclusion criteria may apply
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 |
|---|---|---|
| Drug CocktailSingle oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg) | Drug | Foliglurax |
| FoligluraxFoliglurax | Drug | Foliglurax |
| midazolam ivSingle intravenous (iv) dose of midazolam 0.025 mg/kg | Drug | Foliglurax |
Primary outcome
AUC0-inf
Time frame: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Area under the plasma concentration-time curve from zero to infinity for midazolam after iv administration and for all oral cocktail probe substrates
Cmax
Time frame: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Maximum observed plasma concentration of midazolam after iv administration and for all oral cocktail probe substrates
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 24 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
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 Drug Cocktail, Foliglurax and midazolam iv in people with Healthy, run by H. Lundbeck A/S at 1 site in France.
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 2 inclusion and 2 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 24 Apr 2020. 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 France. 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?
AUC0-inf (time frame: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates). The study lists 2 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 24 Apr 2020.