A Phase I Multiple Oral Dose Trial of Tipranavir 500 mg/Ritonavir 200 mg Dosed to Steady State Followed by Single-dose 14C-radiolabeled Tipranavir Co-administered With Tipranavir 500 mg/Ritonavir 200 mg to Characterize the Excretion Balance and Metabolite Profile of 14C-radiolabeled Tipranavir in Healthy Male Subjects

Boehringer Ingelheim0 个研究点开始时间: 2003年7月最近更新: 2014年10月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Boehringer Ingelheim
主要终点: Radioactive erythrocyte-plasma partition ratio

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记录与标识符相似试验

研究概览

简要总结

Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy HIV-negative male subjects as determined by results of screening. Healthiness was determined by medical history, laboratory testing and 12-lead ECG
•Signed written informed consent in accordance with Good Clinical Practice (GCP)
•Age >18 and <=60 years
•Subjects within 20% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables
•Ability to swallow numerous large capsules
•Willingness to abstain from smoking, ingesting methylxanthine containing drinks or food (coffee, tea, cola, chocolate, etc.), or ingesting alcohol, St. John's Wort, milk thistle, garlic supplements, Seville oranges, and grapefruit or grapefruit juice for the duration of the study

排除标准

•Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
•History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
•History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator and/or the sponsor
•Subjects with a history of drug abuse or alcoholism
•Chronic or relevant acute (within 2 weeks of screening) infections
•Subjects who have taken prescription medications, over-the-counter drugs, or herbal preparations within 2 weeks of the start of the trial
•Participation in another trial with an investigational drug (in the 30 days prior to screening)
•Blood donation >400 mL (within 1 month prior to treatment administration or during the trial)
•Any laboratory value that represents a Division of DAIDS (DAIDS) toxicity Grade >1
•Positive urine drug screen, positive HIV antibody, positive Hepatitis C Ribonucleic acid (RNA), or positive Hepatitis B surface antigen
•History of any familial bleeding disorder

研究组 & 干预措施

TPV/r followed by 14C-radiolabeled TPV

Experimental

Tipranavir/Ritonavir dosed to steady state followed by single-dose 14C-radiolabeled tipranavir co-administered with Tipranavir/Ritonavir

干预措施: 14C-Tipranavir (Drug)

TPV/r followed by 14C-radiolabeled TPV

Experimental

Tipranavir/Ritonavir dosed to steady state followed by single-dose 14C-radiolabeled tipranavir co-administered with Tipranavir/Ritonavir

干预措施: Tipranavir (Drug)

TPV/r followed by 14C-radiolabeled TPV

Experimental

Tipranavir/Ritonavir dosed to steady state followed by single-dose 14C-radiolabeled tipranavir co-administered with Tipranavir/Ritonavir

干预措施: Ritonavir (Drug)