NCT01053520已完成1 期
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female 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
- Abbott
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A .
研究概览
简要总结
This is a Phase 1, randomized, open-label, single center, three period crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 12 healthy female subjects will be enrolled in this study.
详细描述
This is a Phase 1, randomized, open-label, single center, three period crossover study to determine the oral bioavailability of a new ABT-263 formulation relative to that of the current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately 12 healthy female subjects will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female and age is between 18 and 55 years, inclusive.
- •Must be surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), postmenopausal (for at least 2 years), or practicing at least one acceptable method of birth control.
- •Must have negative results for pregnancy tests performed at Screening on a urine sample obtained within 28 days prior to initial study drug administration, and on Period 1 Day -1 on a serum specimen.
- •Body Mass Index (BMI) is 18 to 29, inclusive. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •Must have adequate bone marrow function per local laboratory reference range (Platelets >/= lower limit of normal range, ANC >/= lower limit of normal range)
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- •Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study-specific procedures.
排除标准
- •History of significant sensitivity to any drug
- •History of drug or alcohol abuse w/i 6 months or currently receiving Disulfiram
- •Known/suspected history of HIV
- •History of or active medical condition(s) or surgical procedure(s) that might affect GI motility, pH, absorption
- •History of thrombocytopenic associated bleeding w/i 1 year prior to ABT-263
- •Significant history of cardiovascular disease (e.g., MI, thrombotic or thromboembolic event in last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, respiratory (except mild asthma), gastrointestinal, hematologic, or hepatic disease or diabetes, cancer, epilepsy, or seizures that in the opinion of the PI would adversely affect her participating in the study.
- •Underlying condition predisposing to bleeding or currently exhibits signs of clinically significant bleeding or active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- •Positive result for drugs of abuse, alcohol, cotinine, hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
- •Consumed alcohol, grapefruit or starfruit product, or Seville oranges w/i 3 days prior to ABT-263
- •Received aspirin, anticoagulation therapy, or any drugs or herbal supplements that affect platelet function w/i 7 days prior to/during ABT-263
- •Used any medications, vitamins, or herbal supplements (except contraceptives) w/i 14 days prior to ABT-263
- •Received any drug by injection or biologic agent w/i 30 days prior to ABT-263 (except parenteral hormonal contraceptives)
- •Used known inhibitors or inducers CYP3A w/i 1 month prior to ABT-263; Received any investigational product w/i 6 weeks prior to ABT-263
- •Used tobacco or nicotine-products w/i 6 months prior to ABT-263
- •Pregnant or breastfeeding
- •Donation or loss of >/=550 mL blood or received transfusion of blood product w/i 8 weeks prior ABT-263
- •Currently enrolled in another study.
- •The PI decides the subject is unsuitable to receive ABT-263.
研究组 & 干预措施
Sequence I
Experimental
干预措施: ABT-263 (Drug)
Sequence II
Experimental
干预措施: ABT-263 (Drug)
Sequence III
Experimental
干预措施: ABT-263 (Drug)
结局指标
主要结局
Assess the oral bioavailability of Formulation B1 and Formulation B2 via pharmacokinetic measurements relative to Formulation A .
时间窗: Each formulation assessed via 13 PK timepoints over 4 days
次要结局
- Secondary outcome measures include adverse event monitoring, vital signs, physical examinations, ECGs, and laboratory assessments including pharmacogenetics.(Assessed over the confinement period of 17 days of study duration)
研究者
研究点 (1)
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