A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
- Registration Number
- NCT06673238
- Lead Sponsor
- AbbVie
- Brief Summary
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 88
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).
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Group 1 ABBV-722 Participants will receive a single dose of either ABBV-722 Dose A or placebo. Part 1: Group 1 Placebo Participants will receive a single dose of either ABBV-722 Dose A or placebo. Part 1: Group 2 ABBV-722 Participants will receive a single dose of either ABBV-722 Dose B or placebo. Part 1: Group 2 Placebo Participants will receive a single dose of either ABBV-722 Dose B or placebo. Part 1: Group 3 ABBV-722 Participants will receive a single dose of either ABBV-722 Dose C or placebo. Part 1: Group 3 Placebo Participants will receive a single dose of either ABBV-722 Dose C or placebo. Part 1: Group 4 ABBV-722 Participants will receive a single dose of either ABBV-722 Dose D or placebo. Part 1: Group 4 Placebo Participants will receive a single dose of either ABBV-722 Dose D or placebo. Part 1: Group 5 ABBV-722 Participants will receive a single dose of either ABBV-722 Dose E or placebo. Part 1: Group 5 Placebo Participants will receive a single dose of either ABBV-722 Dose E or placebo. Part 2: Group 6 ABBV-722 Participants who are Han Chinese will receive a single dose of ABBV-722 Dose C. Part 2: Group 7 ABBV-722 Participants who are Japanese will receive a single dose of ABBV-722 Dose C. Part 3: Group 8 ABBV-722 Participants will receive either ABBV-722 Dose B or placebo for 14 days. Part 3: Group 8 Placebo Participants will receive either ABBV-722 Dose B or placebo for 14 days. Part 3: Group 9 ABBV-722 Participants will receive either ABBV-722 Dose C or placebo for 14 days. Part 3: Group 9 Placebo Participants will receive either ABBV-722 Dose C or placebo for 14 days. Part 3: Group 10 ABBV-722 Participants will receive either ABBV-722 Dose D or placebo for 14 days. Part 3: Group 10 Placebo Participants will receive either ABBV-722 Dose D or placebo for 14 days. Part 3: Group 11 ABBV-722 Participants will receive either ABBV-722 Dose E or placebo for 14 days. Part 3: Group 11 Placebo Participants will receive either ABBV-722 Dose E or placebo for 14 days.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events Reported During Safety Evaluations Up to Day 44 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.
Maximum Plasma Concentration (Cmax) of ABBV-722 Up to Day 21 Cmax of ABBV-722.
Time to Cmax (Tmax) of ABBV-722 Up to Day 21 Tmax of ABBV-722.
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722 Up to Day 8 AUCt of ABBV-722.
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722 Up to Day 8 AUCinf of ABBV-722
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722 Up to Day 21 Ctrough of ABBV-722.
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722 Up to Day 21 AUC from AUCtau following the first and last doses of ABBV-722.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722 Up to Day 21 Beta of ABBV-722.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722 Up to Day 21 t1/2 of ABBV-722.
Dose Normalized Cmax Up to Day 21 Dose normalized Cmax.
Dose Normalized AUCs Up to Day 21 Dose normalized AUCs.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 270279
🇺🇸Grayslake, Illinois, United States