Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants
Completed · Phase 1
Conditions studied: Human Immunodeficiency Virus Type 1 (HIV-1), HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00833482
- Run by
- Bristol-Myers Squibb
- People needed
- 185
- Starts
- 2009-09-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2012-10-25
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- West Coast Clinical Trials, Llc — Cypress, California, United States
- Local Institution — Nijmegen, Netherlands
Full record on ClinicalTrials.gov
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