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

A Phase 1, Open-label, Single-center, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Octreotide Acetate Injection (Sandostatin®) on the Pharmacokinetics of Single-dose Telotristat Etiprate in Healthy Male and Female Subjects

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

Study Overview

• Status: Completed
• Conditions: Drug Interactions
• Intervention / Treatment: Drug: Telotristat etiprate; Drug: Octreotide acetate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1; Single oral dose of 500 mg telotristat etiprate on Day 1	Drug: Telotristat etiprate; 500 mg telotristat etiprate
Other: 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	Drug: Telotristat etiprate; 500 mg telotristat etiprate; Drug: Octreotide acetate; 200 µg octreotide acetate three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of telotristat ethyl	Days 1, 2, 3, 6, 7, 8
Plasma concentrations of metabolite LP-778902	Days 1, 2, 3, 6, 7, 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of treatment-emergent adverse events	Up to 39 days

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: LX1606.1-109-NRM; LX1606.109 (Other Identifier: Lexicon Pharmaceuticals, Inc.)