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

• Sponsor: Lexicon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02195635
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Drug Interactions	Drug: Telotristat etiprate; Drug: Octreotide acetate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Oct 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma concentrations of telotristat ethyl [Days 1, 2, 3, 6, 7, 8]

2. Plasma concentrations of metabolite LP-778902 [Days 1, 2, 3, 6, 7, 8]

Secondary Outcome Measures

1. Number of treatment-emergent adverse events [Up to 39 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lexicon Investigational Site	Daytona Beach	Florida	United States	32117

Sponsors and Collaborators

• Lexicon Pharmaceuticals

Investigators

• Study Director: Suman Wason, MD, Lexicon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lexicon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02195635
• Other Study ID Numbers: LX1606.1-109-NRM; LX1606.109
• First Posted: Jul 21, 2014
• Last Update Posted: Sep 7, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Octreotide

Study Results

No Results Posted as of Sep 7, 2016