An Open-Label Food Effect Study of Telotristat Etiprate

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals

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