Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-722
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.
Interventions
DRUGABBV-722
Oral Capsule
DRUGPlacebo
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed