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A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02147808
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.

Condition or disease Intervention/treatment Phase
Drug Interactions Drug: Telotristat etiprate Drug: Midazolam Phase 1

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Study Type : Interventional  (Clinical Trial)
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 Midazolam, a Sensitive P450-3A4 Substrate, in Healthy Male and Female Subjects
Study Start Date : May 2014
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: All subjects
All subjects will receive a single oral midazolam dose on Day 1 while fasting. Days 2 to 4 will be Washout days. On Day 5, subjects will begin a 5-day regimen of telotristat etiprate. On Day 9, subjects will receive a morning dose of telotristat etiprate with a single dose of midazolam while fasting.
Drug: Telotristat etiprate
All subjects will receive two 250 mg telotristat etiprate tablets three times daily.

Drug: Midazolam
All subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]).




Primary Outcome Measures :
  1. Midazolam plasma concentration in combination with steady state telotristat etiprate [ Time Frame: Day 9 ]

Secondary Outcome Measures :
  1. Number of treatment emergent adverse events [ Time Frame: 12 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males and females ≥18 to ≤55 years of age at Screening.
  • Body mass index ≥18.0 to ≤2.0 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 outlines 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
  • Receipt of any investigational agent or study drug within 30 days or 5 half-lives of study start
  • Receipt of any protein- or antibody-based therapeutic agent within 3 months of study start
  • Prior exposure to telotristat etiprate
  • Use of tobacco, smoking cessation products, or nicotine products within 3 months of study start
  • History of major surgery within 6 months of study start
  • History of acute narrow angle glaucoma
  • 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
  • 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
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147808


Locations
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United States, Wisconsin
Lexicon Investigational Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02147808    
Other Study ID Numbers: LX1606.1-108-NRM
LX1606.108 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action