Status:
COMPLETED
Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Human Immunodeficiency Virus Type 1 (HIV-1)
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00833482
Start Date
September 1 2009
End Date
February 1 2011
Last Update
October 25 2012
Active Locations (2)
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1
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
2
Local Institution
Nijmegen, Netherlands, 6425 GA