Healthy
Conditions
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.
Interventions
2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events | 10 days |
Countries
United States
Outcome results
None listed