DDI HV (ATV - Merck)

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518297
• Other study ID #: AI424-352
• Status: Completed
• Phase: Phase 1
• First received: August 17, 2007
• Last updated: February 3, 2010
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2008
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir
Tablet, Oral, 400 mg, twice daily for 5 Days
• Atazanavir
Capsule, Oral, 300 mg, twice daily for 7 Days
• Atazanavir + Raltegravir
Capsule/Tablet, Oral, 300/400, twice daily for 14 Days

Locations

Country	Name	City	State
United States	Bristol-Myers Squibb Clinical Pharmacology Unit	Hamilton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessments		Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge
Primary	Pharmacokinetic Assessments		Days 5, 12, and 26

External Links

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