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

Hepatitis C Clinical Trial

Official title:

Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996879
• Other study ID #: AI443-006
• Status: Completed
• Phase: Phase 1
• First received: October 14, 2009
• Last updated: May 5, 2014
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Midazolam
Syrup, Oral, 5 mg, Single dose, 2 days
• BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 8 days

Locations

Country	Name	City	State
United States	Wcct Global, Llc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax)		Within 24 hours of dosing	No
Secondary	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		On Days 1, 2, 4, 6, 8, 9, and 10	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form