Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00365339

Purpose

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

Condition	Intervention	Phase
HIV Infections	Drug: Atazanavir+Ritonavir+Tenofovir Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Famotidine Aripiprazole Tenofovir Ritonavir BMS 232632 Tenofovir disoproxil Tenofovir Disoproxil Fumarate Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.

Secondary Outcome Measures:

Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.

Estimated Enrollment:	40
Study Start Date:	April 2006

Arms	Assigned Interventions
A: Active Comparator	Drug: Atazanavir+Ritonavir+Tenofovir Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
B: Experimental	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
C: Experimental	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
D: Experimental	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
E: Experimental	Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365339

Locations

United States, New Jersey
Local Institution
Hamilton, New Jersey, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	AI424-287
Study First Received:	August 16, 2006
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00365339 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:

HIV
Protease Inhibitor

Additional relevant MeSH terms:

Anti-Infective Agents
Neurotransmitter Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Famotidine
Therapeutic Uses
Anti-Ulcer Agents
Tenofovir
Aripiprazole

Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
HIV Protease Inhibitors
RNA Virus Infections
Tranquilizing Agents
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Gastrointestinal Agents
Central Nervous System Depressants
Histamine Agents
Enzyme Inhibitors
Atazanavir
Antipsychotic Agents

ClinicalTrials.gov processed this record on February 08, 2010