Drug Interaction Study
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Antivirals/HIV
Intervention: Rifabutin (Drug); Rifabutin + Atazanavir + Ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered
with atazanavir and ritonavir (ATV/RTV)
Clinical Details
Official title: Study to Evaluate the Exposure of Rifabutin Administered in an Alternate Regimen in Combination With Atazanavir and Ritonavir Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Average Area Under the Plasma Concentration-time Curve for 24 Hours (AUC24avg) for Rifabutin (RIB)Maximum Plasma Concentration (Cmax) of RIB Minimum Plasma Concentration (Cmin) of RIB AUC24avg for 25-O-Desacetyl-RIB Cmax of 25-O-Desacetylrifabutin (25-O-Desacetyl-RIB) Cmin of 25-O-Desacetyl-RIB Total Area Under the Plasma Concentration-time Curve (AUCtot)
Secondary outcome: Cmax of ATVCmin of ATV AUC(TAU) for ATV Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV Terminal Elimination Half-life (T-half) of ATV Cmax of RTV Cmin of RTV AUC(TAU) for RTV Tmax of RTV T-half of RTV Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation. Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Platelet Count and Leukocytes Number of Participants With MAs in Hematology: Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP),Aspartate Aminotransferase (AST),Alanine Aminotransferase (ALT),Bilirubin (Total),Bilirubin (Direct),Blood Urea Nitrogen (BUN),Creatinine,Sodium (Serum),Potassium (Serum) Number of Participants With MAs in Serum Chemistry: Chloride (Serum), Calcium (Total), Protein (Total), Bicarbonate, Phosphorous (Inorganic) Number of Participants With MAs in Serum Chemistry: Glucose (Fasting Serum), Albumin, Creatine Kinase, Uric Acid, Lactate Dehydrogenase (LDH) Number of Participants With MAs in Urinalysis Number of Participants With Identified Electrocardiogram (ECG) Abnormalities Number of Participants With Clinically Significant Vital Signs or Physical Examination Findings
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and female subjects between the ages of 18 to 50 years old with a body
mass index (BMI) of 18 to 32 kg/m²
- Prior to enrollment, subjects must have physical and laboratory test findings within
the normal limits, and women of childbearing potential (WOCBP) must have a negative
pregnancy test
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory
determinations
- Use of any prescription drugs or over-the-counter acid controllers within 4 weeks
prior to study drug administration
- Use of any other drugs, including over-the-counter medications of herbal preparations
within 1 week prior to study drug administration
Locations and Contacts
Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey 08690, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: April 2008
Last updated: January 23, 2013
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