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

NCT07024797 | Completed Phase 1

• 1 other identifier: M25-644
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-932

Outcome Measures

Primary Outcomes (13)

• Maximum Plasma Concentration (Cmax) of ABBV-932

  Cmax of ABBV-932

  Up to approximately 43 days

• Time to Cmax (Tmax) of ABBV-932

  Tmax of ABBV-932

  Up to approximately 43 days

• Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932

  Ctrough of ABBV-932

  Up to approximately 43 days

• Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932

  AUCtau of ABBV-932

  Up to approximately 43 days

• Maximum Plasma Concentration (Cmax) of DCAR

  Cmax of DCAR

  Up to approximately 43 days

• Time to Cmax (Tmax) of DCAR

  Tmax of DCAR

  Up to approximately 43 days

• Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR

  Ctrough of DCAR

  Up to approximately 43 days

• Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)

  AUCtau of DCAR

  Up to approximately 43 days

• Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)

  Cmax of DDCAR

  Up to approximately 43 days

• Time to Cmax (Tmax) of DDCAR

  Tmax of DDCAR

  Up to approximately 43 days

• Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR

  Ctrough of DDCAR

  Up to approximately 43 days

• Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR

  AUCtau of DDCAR

  Up to approximately 43 days

• Number of Participants Experiencing Adverse Events

  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.

  Up to approximately 75 days

Study Arms (3)

ABBV-932 or Placebo Part A

EXPERIMENTAL

Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days.

Drug: ABBV-932; Drug: Placebo for ABBV-932

ABBV-932 or Placebo Part B

EXPERIMENTAL

Participants will receive oral ABBV-932 or placebo QD for 14 days.

Drug: ABBV-932; Drug: Placebo for ABBV-932

ABBV-932 or Placebo Part C

EXPERIMENTAL

Participants will receive oral ABBV-932 or placebo QD 42 days.

Drug: ABBV-932; Drug: Placebo for ABBV-932

Interventions

ABBV-932 DRUG

Oral Capsule

ABBV-932 or Placebo Part A; ABBV-932 or Placebo Part B; ABBV-932 or Placebo Part C

Placebo for ABBV-932 DRUG

Oral Capsule

ABBV-932 or Placebo Part A; ABBV-932 or Placebo Part B; ABBV-932 or Placebo Part C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Shanghai Mental Health Center /ID# 273427

Shanghai, Shanghai Municipality, 200030, China

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: August 21, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)