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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


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 ATV

Cmin of 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


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


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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