Drug Interactions
Conditions
Brief summary
To evaluate the effect of octreotide acetate injections (200 µg 3 times daily \[tid\]) on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single-dose telotristat etiprate in healthy male and female subjects
Interventions
500 mg telotristat etiprate
DRUGOctreotide acetate
200 µg octreotide acetate three times daily
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females ≥18 to ≤55 years of age * Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening * Vital signs (after at least 5 minutes resting in a supine position) at Screening that are within the following ranges: Systolic blood pressure, 90 to 140 mm Hg; Diastolic blood pressure, 50 to 90 mm Hg; Heart rate 40 to 100 beats per minute (bpm) * Willing to adhere to the prohibitions and restrictions specified in this protocol * Able to comprehend and willing to sign an Informed Consent Form
Exclusion criteria
* Presence of clinically significant physical, laboratory, or electrocardiogram (ECG) findings at Screening or Check-in (Day 1) that, in the opinion of the Investigator and/or the Sponsor or Sponsor's representative, may interfere with any aspect of study conduct or interpretation of results * Use of any medications (prescription or over-the-counter), herbal tea, energy drinks, herbal products (eg, St. John's Wort, garlic, milk thistle, etc.), or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study, with the exception of those approved by the Investigator and/or the Sponsor or Sponsor's representative * Prior exposure to telotristat etiprate * Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study * History of any major surgery within 6 months prior to Screening * History of renal disease * History of hepatic disease, or significantly abnormal liver function tests (\>1.5 x upper limit of normal \[ULN\]) * History of gall bladder abnormalities * History of any endocrine disorder * History of alcohol or substance abuse within 2 years prior to Screening * Positive urine screen for drugs of abuse and cotinine * Consumption of caffeine- and/or xanthine containing products (eg, cola, coffee, tea, chocolate) within 72 hours prior to Check-in * Consumption of alcohol within 48 hours prior to Check in * Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange containing products within 72 hours prior to Check in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of telotristat ethyl | Days 1, 2, 3, 6, 7, 8 |
| Plasma concentrations of metabolite LP-778902 | Days 1, 2, 3, 6, 7, 8 |
Secondary
| Measure | Time frame |
|---|---|
| Number of treatment-emergent adverse events | Up to 39 days |
Countries
United States
Outcome results
None listed