An Open-Label Food Effect Study of Telotristat Etiprate

NCT ID: NCT02157584

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

Brief Summary

This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fed condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fasted condition.

Group Type: EXPERIMENTAL

Telotristat etiprate

Intervention Type: DRUG

2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)

Treatment B

Subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) on Day 1 in a fasted condition. Days 2 to 5 will be Washout Days. On Day 6, subjects will receive a single 500 mg (as free base) dose of telotristat etiprate (as 2 × 250 mg tablets) 1 in a fed condition.

Group Type: EXPERIMENTAL

Telotristat etiprate

Intervention Type: DRUG

2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)

Interventions

Telotristat etiprate

2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)

Intervention Type: DRUG

Telotristat etiprate

2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult subjects aged ≥18 to ≤55 years of age at screening
• Body mass index ≥18.0 to ≤32.0 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
• Able and willing to ingest an entire high fat/high caloric breakfast meal within 30 minutes
• Willingness to adhere to the restrictions outlined 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 within 14 days of study start
• Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening
• Receipt of any protein- or antibody-based therapeutic agent within 3 months prior to Screening
• Prior exposure to telotristat etiprate
• Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening
• History of major surgery within 6 months prior to Screening
• History of any GI surgery that may induce malabsorption
• 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 at Screening
• 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 Screening
• 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 prior to Screening
• 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 within 72 hours of study start
• 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

• 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

LX1606.107

Identifier Type: OTHER

Identifier Source: secondary_id

LX1606.1-107-NRM

Identifier Type: -

Identifier Source: org_study_id