Expired Study
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Cypress, California 90630


Purpose:

To assess the effects of Voriconazole (VOR) 200 mg twice daily (BID) on the steady-state Pharmacokinetics (PK) of Atazanavir administered as Atazanavir/Ritonavir 300/100 mg once daily (QD) in healthy subjects with functional CYP2C19 alleles. To assess the effects of Atazanavir/Ritonavir 300/100 mg QD on the Pharmacokinetics of Voriconazole 200 mg BID in healthy subjects with functional CYP2C19 alleles.


Criteria:

Inclusion Criteria: - Healthy subjects as determined by no clinically significant deviation from normal - Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² - Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 inclusive Exclusion Criteria: - Women of childbearing potential (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 upon 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 < 40 Kg - Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody - Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption


NCT ID:

NCT00833482


Primary Contact:

Study Director
Bristol-Myers Squibb
Bristol-Myers Squibb


Backup Contact:

N/A


Location Contact:

Cypress, California 90630
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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