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

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: October 14, 2009
Last updated: May 5, 2014
Last verified: May 2014
The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

Condition Intervention Phase
Hepatitis C Drug: Midazolam Drug: BMS-791325 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: May 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00996879

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

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00996879     History of Changes
Other Study ID Numbers: AI443-006
Study First Received: October 14, 2009
Last Updated: May 5, 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
Liver Diseases
Digestive System Diseases
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on July 28, 2017