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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Ritonavir; Voriconazole

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