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

Healthy Volunteers Clinical Trial

Official title:

An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-552 in Healthy Adult Japanese and Han Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686980
• Other study ID #: M23-512
• Status: Completed
• Phase: Phase 1
• Start date: January 17, 2023
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABBV-552
Oral Capsule

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials LLC /ID# 252203	Anaheim	California
United States	PPD Clinical Research Unit -Las Vegas /ID# 252241	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AE)	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.	Up to approximately 45 days
Primary	Maximum Observed Plasma Concentration (Cmax) of ABBV-552	Maximum observed plasma concentration (Cmax) of ABBV-552.	Up to approximately 21 days
Primary	Time to Cmax (Tmax) of ABBV-552	The time to Cmax (Tmax) of ABBV-552.	Up to approximately 21 days
Primary	Terminal Phase Elimination Rate Constant (?z) of ABBV-552	Terminal phase elimination rate constant (?z) of ABBV-552.	Up to approximately 21 days
Primary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-552	Terminal phase elimination half-life (t1/2) of ABBV-552.	Up to approximately 21 days
Primary	Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Measurable Concentration (AUCt) of ABBV-552	AUCt of ABBV-552.	Up to approximately 21 days
Primary	AUC From Time Zero to Infinite Time (AUCinf) of ABBV-552	AUCinf of ABBV-552.	Up to approximately 21 days
Primary	Apparent Oral Clearance (CL/F) of ABBV-552	Apparent oral clearance (CL/F) of ABBV-552.	Up to approximately 21 days
Primary	Apparent Volume of Distribution (Vz/F) of ABBV-552	Apparent volume of distribution (Vz/F) of ABBV-552.	Up to approximately 21 days
Primary	Dose-Normalized Cmax of ABBV-552 (Arm 1)	Dose-normalized Cmax of ABBV-552.	Up to approximately 21 days
Primary	AUC of ABBV-552 (Arm 1)	AUC of ABBV-552.	Up to approximately 21 days

External Links

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