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Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00996879
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Midazolam Drug: BMS-791325 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects
Study Start Date : May 2013
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Midazolam + BMS-791325 Drug: Midazolam
Syrup, Oral, 5 mg, Single dose, 2 days
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 8 days


Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax) [ Time Frame: Within 24 hours of dosing ]

Secondary Outcome Measures :
  1. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests [ Time Frame: On Days 1, 2, 4, 6, 8, 9, and 10 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
  • Women who are not of childbearing potential

Exclusion Criteria:

  • Women of childbearing potential
  • Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
  • Gastrointestinal disease that may impact the absorption of study drug
  • History of any chronic respiratory disease (asthma, COPD)
Contacts and Locations

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): NCT00996879


Locations
United States, California
Wcct Global, Llc
Cypress, California, United States, 90630
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00996879     History of Changes
Other Study ID Numbers: AI443-006
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Bristol-Myers Squibb:
Human Volunteers

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
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