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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Drug Interactions

Treatments: Drug: Octreotide acetate; Drug: Telotristat etiprate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195635

LX1606.1-109-NRM

LX1606.109 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Period 1

Experimental group

Description:

Single oral dose of 500 mg telotristat etiprate on Day 1

Treatment:

Drug: Telotristat etiprate

Period 2

Other group

Description:

Subcutaneous injections of 200 µg octreotide acetate three times daily with a single oral dose of 500 mg telotristat etiprate on Day 6

Treatment:

Drug: Octreotide acetate

Drug: Telotristat etiprate