An Open-label, Randomized, Two-way Crossover Trial of the Effect of a High-Fat Meal on the Pharmacokinetics of Oral Tosedostat (CHR 2797) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety Outcome Measurement
研究概览
简要总结
The objectives of this study are to evaluate the safety and tolerability; and to determine the effect of food on the pharmacokinetics (PK) of CHR-2797 in normal healthy male subjects.
详细描述
This will be a single center, open-label, 2-arm, 2-way, crossover trial to assess the effect of food on CHR-2797 PK following a single 120 mg dose. Approximately 18 normal, healthy male subjects will be enrolled with at least 12 subjects completing the study. Two 60 mg capsules will be administered for a 120 mg dose of CHR-2797 on Days 1 and 8 with a high-fat meal or in the fasted state according to the randomization schedule. Subjects will be confined at the clinical research unit (CRU) from the time of Period 1 Check-in until Clinic Discharge on Day 3, and will return to the CRU on Day 7 for Period 2 Check-in and remain in the CRU until Study Completion (on Day 10 of Period 2). Blood samples for PK analysis will be collected through 48 hours post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects between 18 and 55 years of age, inclusive.
- •Within BMI range of 18.5 to 29.9 kg/m2, inclusive.
- •In good health, determined by no clinically significant ongoing diseases or other conditions that require medication, and/or any other findings from medical history, physical examination, 12-lead ECG, and vital signs.
- •Clinical laboratory evaluations (including chemistry panel fasted [fasted approximately 10 hours], CBC, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
- •Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (does include alcohol; Appendix A).
- •Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus [anti-HCV], and negative HIV antibody screens (Appendix A);
- •Males will either be sterile or agree to use 1 of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives from Check-in (Day -1 of Period 1) until 90 days following Clinic Discharge (Day 10).
- •Able to comprehend and willing to sign an Informed Consent Form (ICF).
排除标准
- •Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).
- •Have a disease or condition that requires daily medication.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed).
- •History or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
- •History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1 of Period 1).
- •Use of any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1 of Period 1).
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in (Day -1 of Period 1).
- •Use of any prescription medications/products within 14 days prior to Check-in (Day 1 of Period 1), unless deemed acceptable by the Investigator;
- •Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
- •Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Check-in (Day -1 of Period 1), unless deemed acceptable by the Investigator.
- •Poor peripheral venous access.
- •Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive.
- •Receipt of blood products within 2 months prior to Check-in (Day -1 of Period 1).
- •Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
研究组 & 干预措施
Treatment A
Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast.
干预措施: CHR-2797 (Drug)
Treatment B
Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal.
干预措施: CHR-2797 (Drug)
结局指标
主要结局
Safety Outcome Measurement
时间窗: 10 days
Report adverse events, vital signs, electrocardiograms, and clinical laboratory test. Averse events, clinical labs, and other safety variables will be analyzed descriptively for all sujects who recieve at least 1 dose of study drug.
Pharmacokinetic Parameter
时间窗: 10 days
For each subject the following PK parameters will be calculated, whevever possible, based on the plasma concentrations of CHR-2797 and its metabolite CHR-79888: * Maximum observed concentration (Cmax) * time to maximum concentration (t-max) * area under the concentration-time curve from Hour 0 to the last measureable concentration (AUC0-t) * apparent terminal elimination rate constant * apparent terminal elimination half-life
次要结局
- Adverse Events(10 days)