Drug InteractionsPhase 1NCT02147808
A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects
A Phase 1 study testing Telotristat etiprate and Midazolam in people with Drug Interactions, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female 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 Interactions
- What is being tested?
- Telotristat etiprate and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2014
- 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 adult males and females ≥18 to ≤55 years of age at Screening.
- Body mass index ≥18.0 to ≤2.0 kg/m^2
- Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
- Willingness to adhere to the restrictions outlines in the protocol
- Able to comprehend and sign the informed consent form.
Who cannot join
- Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
- Use of any medications, herbal tea, energy drink, herbal products, or supplements
- Receipt of any investigational agent or study drug within 30 days or 5 half-lives of study start
- Receipt of any protein- or antibody-based therapeutic agent within 3 months of study start
- Prior exposure to telotristat etiprate
- Use of tobacco, smoking cessation products, or nicotine products within 3 months of study start
Show all 24Show fewer
- History of major surgery within 6 months of study start
- History of acute narrow angle glaucoma
- History of renal disease, or significantly abnormal glomerular filtration rate (<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening
- History of hepatic disease, or significantly abnormal liver function tests
- History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality
- History of any active infection within 14 days prior to first dosing
- History of alcohol or substance abuse within 2 years prior to Screening
- Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
- Concurrent conditions that could interfere with safety and/or tolerability measurements
- Donation or loss of >500 mL of blood or blood product within 3 months
- Women who are breastfeeding or are planning to become pregnant during the study
- Positive serum pregnancy test (females only)
- Positive urine screen for selected drugs of abuse and cotinine
- Consumption of alcohol within 48 hours prior to study start
- Consumption of caffeine- and/or xanthine-containing products
- Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start
- Unable or unwilling to communicate or cooperate with the Investigator for any reason
- Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-Label, Single-Center, 2-Period, Single-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Multiple-Dose Telotristat Etiprate on the Pharmacokinetics of Single-Dose Midazolam, a Sensitive P450-3A4 Substrate, in Healthy Male and Female Subjects
This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.
- Conditions
- Drug Interactions
- Being tested
- Telotristat etiprate, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telotristat etiprateDrug
All subjects will receive two 250 mg telotristat etiprate tablets three times daily.
MidazolamDrug
All subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]).
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects will receive a single oral midazolam dose on Day 1 while fasting. Days 2 to 4 will be Washout days. On Day 5, subjects will begin a 5-day regimen of telotristat etiprate. On Day 9, subjects will receive a morning dose of telotristat etiprate with a single dose of midazolam while fasting. Receives: Drug: Telotristat etiprate; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam plasma concentration in combination with steady state telotristat etiprate
Measured: Day 9
Secondary outcomes (1)
Number of treatment emergent adverse events
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suman Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147808
- Sponsor's protocol ID
- LX1606.1-108-NRM
- Other IDs
- LX1606.108
- Status last verified
- Sep 2014
- First submitted
- 19 May 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Center, 2-Period, Single-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Multiple-Dose Telotristat Etiprate on the Pharmacokinetics of Single-Dose Midazolam, a Sensitive P450-3A4 Substrate, in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02147808
- Acronym / sponsor ID
- LX1606.1-108-NRM
- Conditions
- Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 28 May 2014 (estimated)
- 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 study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: Telotristat etiprate, Drug: MidazolamAll subjects will receive a single oral midazolam dose on Day 1 while fasting. Days 2 to 4 will be Washout days. On Day 5, subjects will begin a 5-day regimen of telotristat etiprate. On Day 9, subjects will receive a morning dose of telotristat etiprate with a single dose of midazolam while fasting. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males and females ≥18 to ≤55 years of age at Screening.
- Body mass index ≥18.0 to ≤2.0 kg/m^2
- Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute
- Willingness to adhere to the restrictions outlines in the protocol
- Able to comprehend and sign the informed consent form.
Key exclusion criteria (24 listed)
- Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator
- Use of any medications, herbal tea, energy drink, herbal products, or supplements
- Receipt of any investigational agent or study drug within 30 days or 5 half-lives of study start
- Receipt of any protein- or antibody-based therapeutic agent within 3 months of study start
- Prior exposure to telotristat etiprate
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 |
|---|---|---|
| Telotristat etiprateAll subjects will receive two 250 mg telotristat etiprate tablets three times daily. | Drug | All subjects |
| MidazolamAll subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]). | Drug | All subjects |
Primary outcome
Midazolam plasma concentration in combination with steady state telotristat etiprate
Time frame: Day 9
1 secondary outcome
Number of treatment emergent adverse events
Time frame: 12 days
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 8 Sep 2014.
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Healthy
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.
Suman Wason, MD study director
Lexicon Pharmaceuticals, Inc.
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 Telotristat etiprate and Midazolam in people with Drug Interactions, run by Lexicon Pharmaceuticals 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 5 inclusion and 24 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 8 Sep 2014. 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?
Midazolam plasma concentration in combination with steady state telotristat etiprate (time frame: Day 9). 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 8 Sep 2014.