Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

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

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

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

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: Octreotide

Criteria

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