A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)
研究概览
简要总结
The objectives of this study are to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of multiple doses of ABT-436 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age is between 18 and 55 years, inclusive.
- •If female, subject must be postmenopausal for at least two years or surgically sterile.
- •Females must have negative results for pregnancy tests prior to study drug administration.
- •If male, subject must be surgically sterile or agree to be sexually inactive or agree to use a barrier method of birth control.
- •Body Mass Index is 18.0 to 29.9 kg/m2 (2 = superscript number), inclusive.
- •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.
- •Must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
排除标准
- •History of significant sensitivity or allergy to any drug.
- •Use of known inhibitors or inducers of CYP3A within 30 days prior to the first dose of study drug and through the end of the study.
- •Requirement for, or use of within the 2-week period prior to study drug administration, any over-the-counter or prescription medication, vitamins, minerals or herbal supplements on a regular basis.
- •Receipt of any depot drug by injection within 30 days prior to study drug administration.
- •Positive screen for drugs of abuse or alcohol, or recent (6-month) history of drug or alcohol abuse.
- •Use of tobacco or other nicotine-containing products within the six-month period preceding study drug administration.
- •Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first dose of study drug.
- •Receipt of an investigational product within a time period equal to 10 half-lives, if known, or a minimum of 6 weeks prior to study drug administration.
- •Has a clinically significant abnormal diastolic blood pressure (< 45 or > 90 mm Hg), systolic blood pressure (< 85 or > 140 mm Hg) or heart rate (< 45 or > 100 bpm).
- •HbA1c > 6.0%.
研究组 & 干预措施
Low dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
干预措施: ABT-436 (Drug)
Low dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
干预措施: Placebo (Drug)
Mid Dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
干预措施: ABT-436 (Drug)
Mid Dose ABT-436
ABT-436 or placebo administered once daily for 7 days.
干预措施: Placebo (Drug)
High Dose ABT-436
ABT-436 or placebo administered once daily for 14 days.
干预措施: ABT-436 (Drug)
High Dose ABT-436
ABT-436 or placebo administered once daily for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)
时间窗: Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)
时间窗: Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)
时间窗: Day -1 through Day 7
次要结局
未报告次要终点