Pharmacokinetic Interaction Study to Evaluate the Pharmacokinetic Effect of Rifabutin on BMS-626529, the Active Moiety of BMS-663068, With and Without Ritonavir in Healthy Subjects

ViiV Healthcare1 个研究点分布在 1 个国家目标入组 102 人开始时间: 2014年5月14日最近更新: 2017年9月25日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: ViiV Healthcare
入组人数: 102
试验地点: 1
主要终点: Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to provide dosing recommendations for the coadministration of BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for prescribing information purposes

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Signed Written Informed Consent
•a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the initiation of any protocol-required procedures
•Target Population
•a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results
•b) Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive BMI = weight (kg)/[height (m)]2
•c) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued the study as a pretreatment failure (ie, subject has not been randomized/has not been dosed). If reenrolled, the subject must be reconsented
•Age and Reproductive Status
•a) Men and women, ages 18 to 50 years, inclusive
•b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
•c) Women must not be breastfeeding
•d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 30 days (duration of ovulatory cycle) for a total of 43 days posttreatment completion
•e) Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 90 days (duration of sperm turnover) for a total of 103 days posttreatment completion

排除标准

•Medical History and Concurrent Diseases
•a) Any significant acute or chronic medical illness as determined by the Investigator.
•b) Current or recent (within 3 months of study drug administration) gastrointestinal disease
•c) Any major surgery within 4 weeks of study drug administration
•d) Any gastrointestinal surgery that could impact upon the absorption of study drug
•e) Intractable diarrhea (≥6 loose stools per day for at least 7 consecutive days) within 30 days prior to the first dose of study drug
•f) History of acute or chronic pancreatitis
•g) History of active or latent tuberculosis or any recent exposure to someone with tuberculosis
•h) History of uveitis and/or current eye or vision problems with the exception of corrective lenses
•i) Contact lens use during study drug administration or the need for contact lenses during study drug administration
•j) Donation of blood to a blood bank or in a clinical study (except screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma donation only)
•k) Blood transfusion within 4 weeks of study drug administration.
•l) History of any hemolytic disorders, including drug-induced hemolysis.
•m) Inability to tolerate oral medication
•n) Inability to be venipunctured and/or tolerate venous access
•o) Recent (within 6 months of study drug administration) history of smoking or current smokers
•p) Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
•q) Any other sound medical, psychiatric, and/or social reason as determined by the Investigator