A Phase 1 First in Human, Single and Multiple Ascending Dose and Food Effect and Drug-Drug Interaction in Healthy Subjects to Evaluate the Safety, Tolerability and Assessment of Pharmacokinetics of ABBV-903
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Terminal Phase Elimination Half-life (t1/2)
研究概览
简要总结
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) is => 18.0 to <= 32 kg/m2 after rounded to the nearest tenth, at Screening and upon initial confinement.
- •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).
排除标准
- •History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
研究组 & 干预措施
Part 1, ABBV-903
Participants will receive a single ascending dose of ABBV-903 in Part 1.
干预措施: ABBV-903 (Drug)
Part 1, Placebo
Participants will receive a single ascending dose of placebo in Part 1.
干预措施: Placebo for ABBV-903 (Drug)
Part 2, ABBV-903
Participants will receive multiple ascending doses of ABBV-903 in Part 2.
干预措施: ABBV-903 (Drug)
Part 2, Placebo
Participants will receive multiple ascending doses of placebo in Part 2.
干预措施: Placebo for ABBV-903 (Drug)
Part 3, Sequence 1
Participants in Part 3 will follow Sequence 1.
干预措施: ABBV-903 (Drug)
Part 3, Sequence 1
Participants in Part 3 will follow Sequence 1.
干预措施: Itraconazole (Drug)
Part 3, Sequence 2
Participants in Part 3 will follow Sequence 2.
干预措施: ABBV-903 (Drug)
Part 3, Sequence 2
Participants in Part 3 will follow Sequence 2.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Terminal Phase Elimination Half-life (t1/2)
时间窗: Baseline to Day 36
Terminal phase elimination half-life (t1/2) will be assessed.
Time to Cmax (Tmax)
时间窗: Baseline to Day 36
Tmax will be assessed.
Apparent Terminal Phase Elimination Constant (β)
时间窗: Baseline to Day 36
Apparent terminal phase elimination constant (β) will be assessed.
Area Under the Plasma Concentration-time Curve (AUC)
时间窗: Baseline to Day 36
AUC will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until the Last Measurable Concentration (AUCt)
时间窗: Baseline to Day 36
AUCt will be assessed.
Maximum Observed Plasma Concentration (Cmax)
时间窗: Baseline to Day 36
Cmax will be assessed.
Area Under the Plasma Concentration-time Curve from Time 0 Until Infinity (AUCinf)
时间窗: Baseline to Day 36
AUCinf will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Baseline to Day 66
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点