Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult Chinese Participants

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteer
• Interventions: Drug: ABBV-932; Drug: Placebo for ABBV-932

• Registration Number: NCT07024797
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-08-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ABBV-932 or Placebo Part A	ABBV-932	Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days.
ABBV-932 or Placebo Part A	Placebo for ABBV-932	Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days.
ABBV-932 or Placebo Part B	ABBV-932	Participants will receive oral ABBV-932 or placebo QD for 14 days.
ABBV-932 or Placebo Part B	Placebo for ABBV-932	Participants will receive oral ABBV-932 or placebo QD for 14 days.
ABBV-932 or Placebo Part C	ABBV-932	Participants will receive oral ABBV-932 or placebo QD 42 days.
ABBV-932 or Placebo Part C	Placebo for ABBV-932	Participants will receive oral ABBV-932 or placebo QD 42 days.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of DCAR	Up to approximately 43 days	Cmax of DCAR
Time to Cmax (Tmax) of DCAR	Up to approximately 43 days	Tmax of DCAR
Time to Cmax (Tmax) of ABBV-932	Up to approximately 43 days	Tmax of ABBV-932
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932	Up to approximately 43 days	Ctrough of ABBV-932
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932	Up to approximately 43 days	AUCtau of ABBV-932
Maximum Plasma Concentration (Cmax) of ABBV-932	Up to approximately 43 days	Cmax of ABBV-932
Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR	Up to approximately 43 days	Ctrough of DCAR
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)	Up to approximately 43 days	AUCtau of DCAR
Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)	Up to approximately 43 days	Cmax of DDCAR
Time to Cmax (Tmax) of DDCAR	Up to approximately 43 days	Tmax of DDCAR
Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR	Up to approximately 43 days	Ctrough of DDCAR
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR	Up to approximately 43 days	AUCtau of DDCAR
Number of Participants Experiencing Adverse Events	Up to approximately 75 days	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.