DDI HV (ATV - Merck)
Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Aug 2007
Shorter than P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 17, 2007
CompletedFirst Posted
Study publicly available on registry
August 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 4, 2010
November 1, 2008
4 months
August 17, 2007
February 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety Assessments
Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge
Pharmacokinetic Assessments
Days 5, 12, and 26
Study Arms (3)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
- Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test
You may not qualify if:
- 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.
- Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
- Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, 08690, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 17, 2007
First Posted
August 20, 2007
Study Start
August 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 4, 2010
Record last verified: 2008-11