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DDI HV (ATV - Merck)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Raltegravir (Drug); Atazanavir (Drug); Atazanavir + Raltegravir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety Assessments

Pharmacokinetic Assessments

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- 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

Locations and Contacts

Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey 08690, United States
Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2007
Last updated: February 3, 2010

Page last updated: August 23, 2015

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