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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Human Immunodeficiency Virus Type 1 (HIV-1); HIV Infections

Treatments: Drug: Atazanavir; Drug: Ritonavir; Drug: Voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833482

2009-009095-13 (EudraCT Number)

AI424-383

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

185 participants in 5 patient groups

Voriconazole, 200 mg BID (EM)

Active Comparator group

Treatment:

Drug: Voriconazole

Atazanavir/Ritonavir, 300/100 QD (EM & PM)

Active Comparator group

Treatment:

Drug: Ritonavir

Drug: Atazanavir

Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)

Active Comparator group

Treatment:

Drug: Voriconazole

Drug: Ritonavir

Drug: Atazanavir

Voriconazole, 50 mg BID (PM)

Active Comparator group

Treatment:

Drug: Voriconazole

Atazanavir/ritonavir, 300/100mgQD+voriconazole, 50mgBID (PM)

Active Comparator group

Treatment:

Drug: Voriconazole

Drug: Ritonavir

Drug: Atazanavir