Healthy Volunteers
Conditions
Keywords
ABBV-552, Alzheimer's disease (AD)
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.
Interventions
DRUGABBV-552
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
\- 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.
Exclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-552 | Up to approximately 21 days | Maximum observed plasma concentration (Cmax) of ABBV-552. |
| Time to Cmax (Tmax) of ABBV-552 | Up to approximately 21 days | The time to Cmax (Tmax) of ABBV-552. |
| 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. |
| 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. |
| AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552 | Up to approximately 21 days | AUCinf of ABBV-552. |
| Apparent Oral Clearance (CL/F) of ABBV-552 | Up to approximately 21 days | Apparent oral clearance (CL/F) 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. |
| AUC of ABBV-552 (Arm 1) | Up to approximately 21 days | AUC of ABBV-552. |
Countries
United States
Outcome results
None listed