Clinical trial NCT06673238: 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
Official title: A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-722
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Adverse Events Reported During Safety Evaluations
timeFrame: Up to Day 44
measure: Maximum Plasma Concentration (Cmax) of ABBV-722
timeFrame: Up to Day 21
measure: Time to Cmax (Tmax) of ABBV-722
timeFrame: Up to Day 21
measure: For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722
timeFrame: Up to Day 8
measure: For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722
timeFrame: Up to Day 8
measure: For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722
timeFrame: Up to Day 21
measure: For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
timeFrame: Up to Day 21
measure: Terminal Phase Elimination Rate Constant (Beta) of ABBV-722
timeFrame: Up to Day 21
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-722
timeFrame: Up to Day 21
measure: Dose Normalized Cmax
timeFrame: Up to Day 21
measure: Dose Normalized AUCs
timeFrame: Up to Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 270279
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: