Clinical trial NCT07024797: Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult Chinese Participants
Official title: A Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Chinese Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-932
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the adverse events, tolerability, and how oral doses of ABBV-932 moves through the body in healthy adult Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 27.9 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, unexplained syncope, or any uncontrolled medical illness.
* History of suicidal ideation within one year prior to study treatment administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts as evidenced by answering "yes" to any suicidal behavior question (except a "yes" to the "Has subject engaged in non-suicidal self-injurious behavior" question) within the last 2 years.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABBV-932
timeFrame: Up to approximately 43 days
measure: Time to Cmax (Tmax) of ABBV-932
timeFrame: Up to approximately 43 days
measure: Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932
timeFrame: Up to approximately 43 days
measure: Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932
timeFrame: Up to approximately 43 days
measure: Maximum Plasma Concentration (Cmax) of DCAR
timeFrame: Up to approximately 43 days
measure: Time to Cmax (Tmax) of DCAR
timeFrame: Up to approximately 43 days
measure: Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR
timeFrame: Up to approximately 43 days
measure: Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)
timeFrame: Up to approximately 43 days
measure: Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)
timeFrame: Up to approximately 43 days
measure: Time to Cmax (Tmax) of DDCAR
timeFrame: Up to approximately 43 days
measure: Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR
timeFrame: Up to approximately 43 days
measure: Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR
timeFrame: Up to approximately 43 days
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 75 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: