An Open-Label Food Effect Study of Telotristat Etiprate

NCT02157584 | Completed Phase 1

• 2 other identifiers: LX1606.1-107-NRMLX1606.107
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of telotristat ethyl

  Days 1, 2, 3, 6, 7, 8

• Plasma concentration of metabolite LP-778902

  Days 1, 2, 3, 6, 7, 8

Secondary Outcomes (1)

• Number of treatment emergent adverse events

  10 days

Study Arms (2)

Treatment A

EXPERIMENTAL

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.

Drug: Telotristat etiprate

Treatment B

EXPERIMENTAL

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.

Drug: Telotristat etiprate

Interventions

Telotristat etiprate DRUG

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

Treatment A

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

telotristat

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 6, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

US (1)