A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects
- Registration Number
- NCT02147808
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects Telotristat etiprate 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. All subjects Midazolam 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.
- Primary Outcome Measures
Name Time Method Midazolam plasma concentration in combination with steady state telotristat etiprate Day 9
- Secondary Outcome Measures
Name Time Method Number of treatment emergent adverse events 12 days
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇺🇸Madison, Wisconsin, United States
Lexicon Investigational Site🇺🇸Madison, Wisconsin, United States