A Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of DCAR
研究概览
简要总结
This study will assess the adverse events, tolerability, and how oral doses of ABBV-932 moves through the body in healthy adult Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body Mass Index (BMI) ≥ 18.0 to ≤ 27.9 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •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
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, unexplained syncope, or any uncontrolled medical illness.
- •History of suicidal ideation within one year prior to study treatment administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts as evidenced by answering "yes" to any suicidal behavior question (except a "yes" to the "Has subject engaged in non-suicidal self-injurious behavior" question) within the last 2 years.
研究组 & 干预措施
ABBV-932 or Placebo Part A
Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days.
干预措施: ABBV-932 (Drug)
ABBV-932 or Placebo Part A
Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days.
干预措施: Placebo for ABBV-932 (Drug)
ABBV-932 or Placebo Part B
Participants will receive oral ABBV-932 or placebo QD for 14 days.
干预措施: ABBV-932 (Drug)
ABBV-932 or Placebo Part B
Participants will receive oral ABBV-932 or placebo QD for 14 days.
干预措施: Placebo for ABBV-932 (Drug)
ABBV-932 or Placebo Part C
Participants will receive oral ABBV-932 or placebo QD 42 days.
干预措施: ABBV-932 (Drug)
ABBV-932 or Placebo Part C
Participants will receive oral ABBV-932 or placebo QD 42 days.
干预措施: Placebo for ABBV-932 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of DCAR
时间窗: Up to approximately 43 days
Cmax of DCAR
Time to Cmax (Tmax) of DCAR
时间窗: Up to approximately 43 days
Tmax of DCAR
Time to Cmax (Tmax) of ABBV-932
时间窗: Up to approximately 43 days
Tmax of ABBV-932
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932
时间窗: Up to approximately 43 days
Ctrough of ABBV-932
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932
时间窗: Up to approximately 43 days
AUCtau of ABBV-932
Maximum Plasma Concentration (Cmax) of ABBV-932
时间窗: Up to approximately 43 days
Cmax of ABBV-932
Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR
时间窗: Up to approximately 43 days
Ctrough of DCAR
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)
时间窗: Up to approximately 43 days
AUCtau of DCAR
Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)
时间窗: Up to approximately 43 days
Cmax of DDCAR
Time to Cmax (Tmax) of DDCAR
时间窗: Up to approximately 43 days
Tmax of DDCAR
Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR
时间窗: Up to approximately 43 days
Ctrough of DDCAR
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR
时间窗: Up to approximately 43 days
AUCtau of DDCAR
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 75 days
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