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An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects

Sponsor
Lexicon Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02157558
Collaborator
(none)
24
Enrollment
1
Location
1
Arm

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
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 Multiple-dose Telotristat Etiprate on the Pharmacokinetics of Single-dose Fexofenadine, a Sensitive P Glycoprotein Substrate, in Healthy Male and Female Subjects
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: All subjects

All subjects will receive a single oral dose of fexofenadine on Day 1 while fasting. Days 2 to 5 will be Washout days. On Day 6, subjects will begin a 5 day telotristat etiprate regimen. On Day 10 subjects will be given the morning telotristat etiprate dose concomitantly with a single dose of fexofenadine while fasting.

Drug: Fexofenadine
All subjects will receive 180 mg fexofenadine

Drug: Telotristat etiprate
All subjects will receive 500 mg (2 X 250 mg tablets) telotristat etiprate tablets three times daily

Outcome Measures

Primary Outcome Measures

  1. Fexofenadine plasma concentration in combination with steady state telotristat etiprate [Day 10]

Secondary Outcome Measures

  1. Number of treatment emergent adverse events [14 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 adult subjects aged ≥18 to ≤55 years of age at screening

  • Body mass index ≥18.0 to ≤32.0 kg/m^2

  • Acceptable vital signs at Screening: Systolic blood pressure = 90-140 mm Hg, Diastolic blood pressure = 50-90 mm Hg, Heart rate = 40-100 beats per minute

  • Willingness to adhere to the restrictions outlined in the protocol

  • Able to comprehend and sign the Informed Consent Form

Exclusion Criteria:

  • Presence of any clinically significant physical, laboratory, or ECG finding that may interfere with the study in the opinion of the Investigator

  • Use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of Day 1

  • Receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to Screening

  • Receipt of any protein- or antibody-based therapeutic agent within 3 months of Screening

  • Prior exposure to telotristat etiprate

  • Use of tobacco, smoking cessation products, or nicotine products within 3 months prior to Screening

  • History of major surgery within 6 months prior to Screening

  • History of any GI surgery that may induce malabsorption

  • History of any serious adverse reaction or hypersensitivity to any component of fexofenadine

  • History of renal disease, or significantly abnormal glomerular filtration rate (<90 mL/min as calculated using the Cockcroft-Gault equation) at Screening

  • History of hepatic disease, or significantly abnormal liver function tests at Screening

  • History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or GI abnormality

  • History of any active infection within 14 days prior to first dosing

  • History of alcohol or substance abuse within 2 years prior to Screening

  • Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens

  • Concurrent conditions that could interfere with safety and/or tolerability measurements

  • Donation or loss of >500 mL of blood or blood product within 3 months prior to Screening

  • Women who are breastfeeding or are planning to become pregnant during the study

  • Positive serum pregnancy test (females only)

  • Positive urine screen for selected drugs of abuse and cotinine

  • Consumption of alcohol within 48 hours prior to study start

  • Consumption of caffeine- and/or xanthine-containing products within 72 hours of study start

  • Consumption of grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 72 hours prior to study start

  • Unable or unwilling to communicate or cooperate with the Investigator for any reason

  • Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of CYP3A4 within 30 days prior to the first dose

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lexicon Investigational Site Dallas Texas United States 75247

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:
NCT02157558
Other Study ID Numbers:
  • LX1606.1-106-NRM
  • LX1606.106
First Posted:
Jun 6, 2014
Last Update Posted:
Sep 8, 2014
Last Verified:
Sep 1, 2014
Additional relevant MeSH terms:
Fexofenadine

Study Results

No Results Posted as of Sep 8, 2014