- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00904059
Drug-Drug Interaction Study in Healthy Subjects
January 6, 2011 updated by: Bristol-Myers Squibb
Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects
The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pharmacokinetics and Safety in Healthy Subjects
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78744
- PPD Development, LP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 49 years
- Females who are not of childbearing potential, pregnant or breastfeeding
- Subject Body Mass Index (BMI) of 18 to 32 kg/m²
Exclusion Criteria:
- Women of child bearing potential
- Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Prior exposure to BMS-650032 or BMS-790052
- Positive for HIV or HCV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group A
|
Capsules, Oral, 600 mg, Q12h, Days 1-7
Capsules, Oral, 200 mg, Q12h, Days 8-21
|
Experimental: Treatment Group B
|
Capsules, Oral, 60 mg, Q24h, Days 1-7
Capsules, Oral, 30 mg, Q24h, Days 8-21
|
Experimental: Treatment Group C
Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)
|
Capsules, Oral, 600 mg, Q12h, Days 1-7
Capsules, Oral, 200 mg, Q12h, Days 8-21
Capsules, Oral, 60 mg, Q24h, Days 1-7
Capsules, Oral, 30 mg, Q24h, Days 8-21
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin
Time Frame: Day 21 pharmacokinetic assessment
|
Day 21 pharmacokinetic assessment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered
Time Frame: Within 24 hours post dose
|
Within 24 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
April 21, 2009
First Submitted That Met QC Criteria
May 18, 2009
First Posted (Estimate)
May 19, 2009
Study Record Updates
Last Update Posted (Estimate)
January 7, 2011
Last Update Submitted That Met QC Criteria
January 6, 2011
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI447-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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