Healthy subjects
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent 2) Target population: a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. b) Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. 3) Men and women, ages 18 to 50 years inclusive. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and after the study in such a manner that the risk of pregnancy is minimized. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Sex and Reproductive Status a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for a period of at least 1 month before and after the study. b) WOCBP using a prohibited contraceptive method within 3 months of first study dose. c) Women who are pregnant or breastfeeding d) Women with a positive pregnancy test on enrollment or prior to study drug administration. 2) Medical History and Concurrent Diseases a) Any significant acute or chronic medical illness. b) Current or recent (within 3 months) gastrointestinal disease. c) Any major surgery within 4 weeks of first dose of study drug. d) Any gastrointestinal surgery that could impact upon the absorption of study drug. e) Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of first dose of study drug. f) Blood transfusion within 4 weeks of first dose of study drug. g) Inability to tolerate oral medication. h) Inability to be venipunctured and/or tolerate venous access. i) Recent (within 6 months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse (see Protocol Appendix 4) j) Any other sound medical, psychiatric and/or social reason as determined by the Investigator. k) Smoking more than 10 cigarettes per day. l) History of nephrolithiasis. m) History of acute or chronic pancreatitis. n) History of any hemolytic disorders. o) Proven or suspected acute hepatitis. p) Known or suspected HIV, HBV or HCV infection. 3) Physical and Laboratory Test Findings a) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations. b) Positive urine screen for drugs of abuse either at screening or before each dose of study drug. c) Positive blood screen for hepatitis B and/or C antibodies. d) Positive blood screen for HIV-1;-2 antibodies. e) Positive pregnancy test for females. f) Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 80 mL/min. g) Liver enzymes (total bilirubin, alkaline phosphatase, AST, ALT) above the upper limit of normal. h) QTc interval > 450 msec for males or > 470 msec for females. i) Second- or third-degree A-V block or clinically relevant ECG abnormalities. 4) Allergies and Adverse Drug Reactions a) History of allergy to atazanavir, ritonavir or related compounds. b) History of any significant drug allergy. c) Inability to tolerate or history of allergy to any of the foods described in the standard light and high-fat meals. 5) Prohibited Therapies and/or Medications a) Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug. b) Use of any prescription drugs or over-the-counter acid controllers within 4 weeks of first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To assess, in healthy subjects, the effect of a light or high-fat meal on the pharmacokinetics of a single dose of RTV 100 mg, when administered in combination with ATV 300 mg. - To assess, in healthy subjects, the safety of a single dose of ATV 300 mg when administered in combination with RTV 100 mg. ; Primary end point(s): Pharmacokinetic Measures: Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), and T-HALF) will be derived from plasma concentration versus time after fasting and a light or high-fat meal. Primary Safety Outcome Measures: Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance. ;Main Objective: To assess, in healthy subjects, the effect of a light or high-fat meal on the single dose pharmacokinetics of ATV 300 mg, when administered in combination with RTV 100 mg. | — |
Countries
United Kingdom
Outcome results
None listed