ACTRN12611001058965尚未招募1 期
A Phase 1 Single Center, Open-Label, Randomized, Sequential Dose-Ascending Cross-Over Study to Evaluate the Pharmacokinetics and Tolerability of CTP-298 Amorphous Dispersion (450 mg, 550 mg, and 650 mg) at Steady State Compared to Atazanavir (300 mg) Coadministered With Ritonavir (100 mg) at Steady State in Healthy Male Adults
CoNCERT Pharmaceuticals0 个研究点目标入组 36 人开始时间: 2011年10月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
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 investigator, 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. A subject with a non-clinically significant abnormality or laboratory parameters outside the reference range may be included only if the investigator considers that the finding will not compromise the subject’s safety and will not interfere with the study procedures or data interpretation.
- •2. Healthy adult males between 18 and 50 years of age, inclusive
- •3. Body weight > or = 50 kg and BMI within the range of 18 to 30 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. Willing and able to be confined at the clinical research center for the study days
- •6. Negative tests for selected drugs of abuse, cotinine, and alcohol at screening and Day -1
- •7. 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 (including nephrolithiasis), hepatic, or gastrointestinal (GI) conditions; or history of such conditions that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial, may interfere with the interpretation of safety and/or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of the study drugs
- •2. PR interval > or = 220 msec or QRS duration > or = 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. These laboratory tests may be repeated once, if they are abnormal on first screening, and if there is a medical reason to believe the results may be inaccurate. If the repeat test is within the reference range, the subject may be included only if the investigator considers that the previous finding will not compromise the subject’s safety and will not interfere with the interpretation of safety data.
- •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 greater than trace blood, 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; to be verified by a negative urine cotinine screen at screening and prior to the first dose of study drug
- •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. (The subject may take paracetamol (< or = 2 grams/day) or ibuprofen (< or = 1600 mg/day) for up to 48 hours prior to the first dose of study drug. If currently taking medications that are prescribed or recommended by a physician, no medication should be stopped for the purposes of study participation without agreement by that physician.
- •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
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