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Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

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

Condition(s) targeted: Human Immunodeficiency Virus Type 1 (HIV-1); HIV Infections

Intervention: Voriconazole (Drug); Atazanavir (Drug); Ritonavir (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

This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.

Clinical Details

Official title: Study to Assess the Pharmacokinetic Drug - Drug Interactions Between Atazanavir Plus Ritonavir Coadministered With Voriconazole in Healthy Subjects

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

Primary outcome:

Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)

Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants

Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants

AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants

Secondary outcome:

Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE

Number of Participants With Marked Abnormalities in Serum Chemistry Test Results

Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results

Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator

Number of Participants With Abnormalities in Vital Signs

Eligibility

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

Criteria:

Inclusion Criteria:

- Healthy participants as determined by no clinically significant deviation from normal

- Body Mass Index (BMI) of 18 to 32 kg/m^2, inclusive. BMI=weight(kg)/height (m)^2

- Women who are not of childbearing potential (WOCBP)(ie, who are postmenopausal or

surgically sterile) and men, ages 18 to 45 years, inclusive Exclusion Criteria:

- WOCBP

- Sexually active fertile men not using effective birth control if their partners are

WOCBP

- Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)

- Any significant acute or chronic medical illness

- Any gastrointestinal surgery that could impact on the absorption of study drug

- Smoking more than 5 cigarettes per day

- History of any hemolytic disorders (including drug-induced hemolysis)

- History of acute or chronic pancreatitis

- History of hypochlorhydria or achlorhydria

- Men and women weighing <40 kg

- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1

or HIV-2 antibody

- Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose

malabsorption

Locations and Contacts

Local Institution, Nijmegen 6425 GA, Netherlands

West Coast Clinical Trials, Llc, Cypress, California 90630, United States

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

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

Starting date: September 2009
Last updated: September 24, 2012

Page last updated: August 23, 2015

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