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

NCT ID: NCT02195635

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

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

Conditions

Drug Interactions

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Period 1

Single oral dose of 500 mg telotristat etiprate on Day 1

Group Type: EXPERIMENTAL

Telotristat etiprate

Intervention Type: DRUG

500 mg telotristat etiprate

Period 2

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

Group Type: OTHER

Telotristat etiprate

Intervention Type: DRUG

500 mg telotristat etiprate

Octreotide acetate

Intervention Type: DRUG

200 µg octreotide acetate three times daily

Interventions

Telotristat etiprate

500 mg telotristat etiprate

Intervention Type: DRUG

Octreotide acetate

200 µg octreotide acetate three times daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Lexicon Investigational Site

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

LX1606.109

Identifier Type: OTHER

Identifier Source: secondary_id

LX1606.1-109-NRM

Identifier Type: -

Identifier Source: org_study_id