ACTRN12610001080011招募中1 期
An open-labeled, randomized, crossover, single-dose study in healthy male Participants to evaluate the pharmacokinetics, safety, and tolerability of stable isotopologs of atazanavir (ATV), administered as single agents or as combinations of two isotopologs, with a pharmacokinetic comparison to Reyataz(Registered Trademark)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Male
入选标准
- •1. Healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
- •2. Healthy adult males between 18 and 50 years of age, inclusive
- •3. Body weight greater than or equal to 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening
- •4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol
- •5. Negative tests for selected drugs of abuse, cotinine, and alcohol at screening and Day -1
- •6. Dietary habits that fall within the range of normal, as determined by the investigator. Examples of unusual diets are liquid diets, protein-only diets, high fat-diets, or lowcarbohydrate diets.
- •8. Willingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness of male subjects to use a condom and spermicide, in addition to having the female partner use another form of contraception such as an intrauterine device, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation. This criterion must be followed from the time of first study drug administration until 30 days after the final administration of study drug.
排除标准
- •1. History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
- •2. PR interval = 220 msec or QRS duration = 120 msec or QT interval > 450 msec obtained at screening visit or prior to the first dose of study drug
- •3. Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), serum creatinine, or bilirubin > upper limit of normal (ULN) at screening or prior to the first dose of study drug.
- •4. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
- •5. Urinalysis positive for protein or glucose (greater than trace findings of protein or glucose) at screening or prior to the first dose of study drug
- •6. History of drug abuse within 6 months of screening
- •7. History of any tobacco product use within 3 months prior to the study,
- •8. Participation in a clinical trial and receipt of an investigational medication or a new chemical entity within 30 days, 5 half-lives, or twice the duration of the biological effect of any medication (whichever is longer) prior to the first dose of current study drug
- •9. Use of prescription or non-prescription medications, including herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or use of St. John’s Wort within 14 days prior to the first dose of study drug.
- •10. Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, or red wine within 7 days prior to administration of study drug
- •11. Consumption of any caffeine and/or xanthine products (ie, coffee, tea, chocolate and caffeine containing sodas, colas, etc) within 48 hours prior to each dose of study drug and while confined at the clinical site
- •12. Donation of blood or blood products or blood collection in excess of 470 mL within 8 weeks prior to dosing
- •13. History of sensitivity to any of the study drugs or components thereof, or a history of medication allergy or other allergy that, in the opinion of the investigator, contraindicates study participation
- •14. Unwillingness to comply with protocol-specified lifestyle and/or dietary restrictions
- •15. Major surgery within 4 weeks of screening
- •16. Uncontrolled intercurrent illness (ie, active infection)
研究者
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