A Study to Assess the Adverse Events and How Oral ABBV-552 Capsules Moves Through the Body of Healthy Adult Japanese and Han Chinese Participants
- Registration Number
- NCT05686980
- Lead Sponsor
- AbbVie
- Brief Summary
This study will assess how safe ABBV-552 is and how ABBV-552 moves through the body of adult healthy Japanese and Han Chinese participants. Adverse Events will be assessed.
ABBV-552 is an investigational drug being developed for potential treatment of Alzheimer's disease (AD). Approximately 18 adult healthy Japanese and Han Chinese volunteers will be enrolled in 2 sites in the United States.
Japanese participants assigned to Arm 1 will receive ascending doses of ABBV-552 oral capsules once every week for 3 weeks. Han Chinese participants assigned to Arm 2 will receive oral ABBV-552 capsules on Day 1. All participants will be followed for 30 days after their last dose.
Participants will be confined for 22 days or 8 days depending on the Arm they are assigned to. Adverse Events and blood tests will be performed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Japanese participants 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.
OR
- Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- Has no other clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive ABBV-552.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Healthy Japanese Participants ABBV-552 Participants will receive ABBV-552 once a week for 21 Days. Arm 2: Healthy Han Chinese Participants ABBV-552 Participants will receive ABBV-552 once a week for 7 Days.
- Primary Outcome Measures
Name Time Method AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552 Up to approximately 21 days AUCinf of ABBV-552.
Maximum Observed Plasma Concentration (Cmax) of ABBV-552 Up to approximately 21 days Maximum observed plasma concentration (Cmax) of ABBV-552.
Number of Participants With Adverse Events (AE) Up to approximately 45 days An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Terminal Phase Elimination Rate Constant (λz) of ABBV-552 Up to approximately 21 days Terminal phase elimination rate constant (λz) of ABBV-552.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-552 Up to approximately 21 days Terminal phase elimination half-life (t1/2) of ABBV-552.
Time to Cmax (Tmax) of ABBV-552 Up to approximately 21 days The time to Cmax (Tmax) of ABBV-552.
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUCt) of ABBV-552 Up to approximately 21 days AUCt of ABBV-552.
Apparent Volume of Distribution (Vz/F) of ABBV-552 Up to approximately 21 days Apparent volume of distribution (Vz/F) of ABBV-552.
Dose-Normalized Cmax of ABBV-552 (Arm 1) Up to approximately 21 days Dose-normalized Cmax of ABBV-552.
Apparent Oral Clearance (CL/F) of ABBV-552 Up to approximately 21 days Apparent oral clearance (CL/F) of ABBV-552.
AUC of ABBV-552 (Arm 1) Up to approximately 21 days AUC of ABBV-552.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Anaheim Clinical Trials LLC /ID# 252203
🇺🇸Anaheim, California, United States
PPD Clinical Research Unit -Las Vegas /ID# 252241
🇺🇸Las Vegas, Nevada, United States