Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects
Phase 1
Completed
- Conditions
- Drug Interactions
- Interventions
- Registration Number
- NCT02195635
- Lead Sponsor
- Lexicon Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Period 1 Telotristat etiprate Single oral dose of 500 mg telotristat etiprate on Day 1 Period 2 Telotristat etiprate Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6 Period 2 Octreotide acetate Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6
- Primary Outcome Measures
Name Time Method Plasma concentrations of metabolite LP-778902 Days 1, 2, 3, 6, 7, 8 Plasma concentrations of telotristat ethyl Days 1, 2, 3, 6, 7, 8
- Secondary Outcome Measures
Name Time Method Number of treatment-emergent adverse events Up to 39 days
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇺🇸Daytona Beach, Florida, United States