A Study to Assess How the Drug Moves Through the Body, Ad... | NCT06673238

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1: Group 1	Experimental	Participants will receive a single dose of either ABBV-722 Dose A or placebo.	Drug: ABBV-722 Drug: Placebo
Part 1: Group 2	Experimental	Participants will receive a single dose of either ABBV-722 Dose B or placebo.	Drug: ABBV-722 Drug: Placebo
Part 1: Group 3	Experimental	Participants will receive a single dose of either ABBV-722 Dose C or placebo.	Drug: ABBV-722 Drug: Placebo
Part 1: Group 4	Experimental	Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.	Drug: ABBV-722 Drug: Placebo
Part 1: Group 5	Experimental	Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.	Drug: ABBV-722 Drug: Placebo
Part 2: Group 6

Name	Type	Description	Arm Group Labels	Other Names
ABBV-722	Drug	Oral Capsule	Part 1: Group 1 Part 1: Group 2 Part 1: Group 3 Part 1: Group 4 Part 1: Group 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events Reported During Safety Evaluations	Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.	Up to Day 44
Maximum Plasma Concentration (Cmax) of ABBV-722	Cmax of ABBV-722.	Up to Day 21
Time to Cmax (Tmax) of ABBV-722	Tmax of ABBV-722.	Up to Day 21
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722	AUCt of ABBV-722.	Up to Day 8
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722	AUCinf of ABBV-722	Up to Day 8
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722	Ctrough of ABBV-722.	Up to Day 21
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722	AUC from AUCtau following the first and last doses of ABBV-722.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Laboratory values meet the criteria specified in the protocol.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.
- Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
- Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR
- Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- First-generation participants will have been born in Japan to two parents and four grandparents, who were also born in Japan, and are of full Japanese descent.
- Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.

Exclusion Criteria:

History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.

Facility	Status	City	State	ZIP	Country	Contacts
Altasciences Clinical Los Angeles /ID# 280183		Cypress	California	90630	United States
Acpru /Id# 270279