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

NCT ID: NCT02147808

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Telotristat etiprate

Intervention Type: DRUG

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

Midazolam

Intervention Type: DRUG

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

Interventions

Telotristat etiprate

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

Intervention Type: DRUG

Midazolam

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Lexicon Investigational Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

LX1606.108

Identifier Type: OTHER

Identifier Source: secondary_id

LX1606.1-108-NRM

Identifier Type: -

Identifier Source: org_study_id