A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects

NCT02147808 | Completed Phase 1

• 2 other identifiers: LX1606.1-108-NRMLX1606.108
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Midazolam plasma concentration in combination with steady state telotristat etiprate

  Day 9

Secondary Outcomes (1)

• Number of treatment emergent adverse events

  12 days

Study Arms (1)

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.

Drug: Telotristat etiprate; Drug: Midazolam

Interventions

Telotristat etiprate DRUG

All subjects will receive two 250 mg telotristat etiprate tablets three times daily.

All subjects

Midazolam DRUG

All subjects will receive 3 mg (1.5 mL oral syrup \[2mg/mL\]).

All subjects

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

telotristat; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

US (1)