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

This study is currently recruiting participants.
Verified June 2013 by Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: October 14, 2009
Last updated: June 7, 2013
Last verified: June 2013

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: Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: May 2013
Estimated Study Completion Date: September 2013
Estimated 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
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT00996879

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

United States, California
Wcct Global, Llc Recruiting
Cypress, California, United States, 90630
Contact: Michelle D Ababa, Site 0002    714-252-0700      
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT00996879     History of Changes
Other Study ID Numbers: AI443-006
Study First Received: October 14, 2009
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Human Volunteers

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 16, 2014