NCT01896323已完成1 期
An Open-Label, Two-Period, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Ketoconazole on the Single Dose Pharmacokinetics of CC-223 in Healthy Adult Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 14
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.
详细描述
This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.
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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must understand and voluntarily sign a written informed consent form before participation.
- •Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- •Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.
- •For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.
- •Must have a body mass index between 18 and 33 kilograms/meter squared.
- •Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
- •Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
- •Must have a normal or clinically acceptable 12-lead electrocardiogram.
排除标准
- •History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
- •Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- •Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.
- •Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.
- •Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
- •Donated blood or plasma within 2 months before the first dose of study drug.
- •History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.
- •History of alcohol abuse within 2 years before dosing, or positive alcohol screen.
- •Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen, or hepatitis C antibody, or have a positive result to the test for Human Immune virus antibodies at Screening.
- •Exposed to an investigational drug within one month 30 days before the first dose of study drug.
- •Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.
研究组 & 干预措施
CC-223
Experimental
CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2
干预措施: CC-223 (Drug)
Ketokonazole
Active Comparator
Ketoconazole administration on study days 1 through 8 of Period 2
干预措施: Ketoconazole (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: up to 96 hours post dose
t½ - terminal elimination half-life in plasma
次要结局
- Adverse Events(Up to 28 days after last dose of study drug)
研究者
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