Status:
COMPLETED
Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Drug Interactions
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 sing...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02195635
Start Date
July 1 2014
Last Update
September 7 2016
Active Locations (1)
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1
Lexicon Investigational Site
Daytona Beach, Florida, United States, 32117