A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT02147808|
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : September 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Drug Interactions||Drug: Telotristat etiprate Drug: Midazolam||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 2014|
Experimental: All subjects
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.
Drug: Telotristat etiprate
All subjects will receive two 250 mg telotristat etiprate tablets three times daily.
All subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]).
- Midazolam plasma concentration in combination with steady state telotristat etiprate [ Time Frame: Day 9 ]
- Number of treatment emergent adverse events [ Time Frame: 12 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147808
|United States, Wisconsin|
|Lexicon Investigational Site|
|Madison, Wisconsin, United States, 53704|
|Study Director:||Suman Wason, MD||Lexicon Pharmaceuticals, Inc.|