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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Raltegravir; Drug: Atazanavir; Drug: Atazanavir + Raltegravir

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: Atazanavir; Capsule, Oral, 300 mg, twice daily for 7 Days; Other Names: Reyataz
Active Comparator: 1	Drug: Raltegravir; Tablet, Oral, 400 mg, twice daily for 5 Days
Active Comparator: 3	Drug: Atazanavir + Raltegravir; Capsule/Tablet, Oral, 300/400, twice daily for 14 Days; Other Names: Reyataz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: August 17, 2007
• First Submitted That Met QC Criteria: August 17, 2007
• First Posted (Estimate): August 20, 2007

Study Record Updates

• Last Update Posted (Estimate): February 4, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Antivirals / HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Raltegravir Potassium; Atazanavir Sulfate
• Other Study ID Numbers: AI424-352