NCT02117245已完成不适用
Phase I Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Peak Plasma concentration (Cmax) of MGCD265.
研究概览
简要总结
The objective of this study is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.
详细描述
The study objective is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteer
- •Volunteer age of 40 to 65 years
- •Females of childbearing potential using a stable contraceptive method at least 14 days prior to screening and willing to use acceptable birth control methods from 7 days prior to first dose until 30 days after last dose of study drug:
- •Female volunteers will be considered of non childbearing potential and eligible if:
- •Amenorrhea for at least 1 year;
- •Hysterectomy;
- •Bilateral oophorectomy at least 6 weeks prior to first dose;
- •Bilateral tubal ligation at least 6 months prior to first dose;
- •Hysteroscopic sterilization.
- •Male volunteers who agree to be abstinent or use acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 90 days after the last dose of study drug:
- •Male volunteers who also agree to not donate sperm from the time of taking the first dose until 90 days after the last dose.
- •Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
- •Non- or ex smokers for at least 6 months.
- •Availability for the entire study period
- •Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements
- •Clinical laboratory values within the laboratory's stated normal range; or they must be without any clinical significance
- •Have no clinically significant diseases captured in medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations
- •Willingness to adhere to protocol requirements
- •The informed consent form must be signed by all volunteers, prior to participation in the study.
排除标准
- •Females who are pregnant or are lactating
- •History of significant hypersensitivity reactions to any substance or drug
- •History or presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Seated blood pressure higher than and equal to 140/90 mmHg at screening
- •Seated blood pressure higher than and equal to 140/90 mmHg before drug administration
- •History or predisposition to cardiovascular illness
- •History or predisposition to thrombotic or hemorrhagic events, bleeding diathesis or coagulopathy, gastrointestinal or other conditions with risk of perforation, presence of a non-healing wound, ulcer or fracture
- •Presence of significant pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- •No major surgery within 28 days prior to first dose
- •Suicidal tendency, disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- •Presence of out-of-range cardiac interval or ECG abnormalities
- •Maintenance therapy with any drug, or history of drug dependency or alcohol abuse
- •Any clinically significant illness in the previous 28 days before day 1 of study
- •Use of any enzyme-modifying drugs in the previous 28 days before day 1 of study
- •Use of any drugs known to induce or inhibit hepatic metabolism in the previous 28 days before day 1 of study
- •Any history of tuberculosis and/or prophylaxis for tuberculosis
- •Positive urine screening of ethanol and/or drugs of abuse
- •Positive results to HIV, HBsAg or anti-Hepatitis C Virus tests
- •Females who are pregnant
- •Volunteers who took an Investigational Product or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- •Donation of 500 mL or more of blood in the previous 56 days before day 1 of this study
结局指标
主要结局
Peak Plasma concentration (Cmax) of MGCD265.
时间窗: 26 days
Bioavailability of study drug under fed conditions compared to fasting conditions in healthy male and female volunteers.
次要结局
未报告次要终点
研究者
研究点 (1)
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