A Phase 1 Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
研究概览
简要总结
This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（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 < = 32.0 kg/m^2 after rounded to the tenths decimal, at Screening and upon 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 ECG.
- •Part 3 Only: Han Chinese Participant must be first-or second-generation Han Chinese of full Chinese parentage. First-generation participants will have been born in China to two participants and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR
- •Japanese Participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
排除标准
- •Part 1 (Groups 1-4), Part 2 and Part 3: History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.
研究组 & 干预措施
Part 1: Group 1 ABBV-1088 Dose A
Participants will receive ABBV-1088 dose A for 7 days
干预措施: ABBV-1088 (Drug)
Part 1: Group 1 Placebo
Participants will receive placebo for 7 days
干预措施: Placebo for ABBV-1088 (Drug)
Part 1: Group 2 ABBV-1088 Dose B
Participants will receive ABBV-1088 dose B for 21 days
干预措施: ABBV-1088 (Drug)
Part 1: Group 2 Placebo
Participants will receive placebo for 21 days
干预措施: Placebo for ABBV-1088 (Drug)
Part 1: Group 3 ABBV-1088 Dose C
Participants will receive ABBV-1088 dose C for 7 days
干预措施: ABBV-1088 (Drug)
Part 1: Group 3 Placebo
Participants will receive placebo for 7 days
干预措施: Placebo for ABBV-1088 (Drug)
Part 1: Group 4 ABBV-1088 Dose D
Participants will receive ABBV-1088 dose D for 21 days
干预措施: ABBV-1088 (Drug)
Part 1: Group 4 Placebo
Participants will receive placebo for 21 days
干预措施: Placebo for ABBV-1088 (Drug)
Part 1: Group 5 ABBV-1088 Dose D
Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days
干预措施: ABBV-1088 (Drug)
Part 1: Group 5 Placebo
Participants older than 60 years of age will receive placebo for 21 days
干预措施: Placebo for ABBV-1088 (Drug)
Part 2: Period 1 ABBV-1088 Dose A
Participants will receive ABBV-1088 Dose A on day 1
干预措施: ABBV-1088 (Drug)
Part 2: Period 2 ABBV-1088 Dose A with ITZ
Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days
干预措施: ABBV-1088 (Drug)
Part 2: Period 2 ABBV-1088 Dose A with ITZ
Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days
干预措施: Itraconazole (ITZ) (Drug)
Part 3: Group 1 ABBV-1088 Han Chinese Participants
Han Chinese participants will receive ABBV-1088 dose E on day 1
干预措施: ABBV-1088 (Drug)
Part 3: Group 2 ABBV-1088 Japanese Participants
Japanese participants will receive ABBV-1088 dose E on day 1
干预措施: ABBV-1088 (Drug)
结局指标
主要结局
Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
时间窗: Up to approximately 24 days
Cmax of ABBV-1088
Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088
时间窗: Up to approximately 24 days
Tmax of ABBV-1088
Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
时间窗: Up to approximately 24 days
Terminal phase elimination rate constant (beta) of ABBV-1088
Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
时间窗: Up to approximately 24 days
Terminal phase elimination half-life of ABBV-1088
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088
时间窗: Up to approximately 24 days
AUCt of ABBV-1088
Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088
时间窗: Up to approximately 24 days
AUCinf of ABBV-1088
Part 1: Trough Concentration (Ctrough) of ABBV-1088
时间窗: Up to approximately 24 days
Ctrough of of ABBV-1088
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 54 days
An adverse event (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 An adverse event (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. The investigator assesses the relationship of each event to the use of study
Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau)
时间窗: Up to approximately 24 days
The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).
次要结局
未报告次要终点