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

Information source: Lexicon Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Interactions

Intervention: Fexofenadine (Drug); Telotristat etiprate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Lexicon Pharmaceuticals

Official(s) and/or principal investigator(s):
Suman Wason, MD, Study Director, Affiliation: Lexicon Pharmaceuticals, Inc.

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.

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Fexofenadine plasma concentration in combination with steady state telotristat etiprate

Secondary outcome: Number of treatment emergent adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Lexicon Investigational Site, Dallas, Texas 75247, United States
Additional Information

Starting date: July 2014
Last updated: September 5, 2014

Page last updated: August 23, 2015

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