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

NCT02195635 | Completed Phase 1

• 2 other identifiers: LX1606.1-109-NRMLX1606.109
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of treatment-emergent adverse events

  Up to 39 days

Study Arms (2)

Period 1

EXPERIMENTAL

Single oral dose of 500 mg telotristat etiprate on Day 1

Drug: Telotristat etiprate

Period 2

OTHER

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; Drug: Octreotide acetate

Interventions

Telotristat etiprate DRUG

500 mg telotristat etiprate

Period 1; Period 2

Octreotide acetate DRUG

200 µg octreotide acetate three times daily

Period 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

telotristat; Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

US (1)