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Completed

NCT Number: NCT07024797

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

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Mental Health Center /ID# 273427

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Placebo for ABBV-932

Drug

Oral Capsule

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-932

    Time frame: Up to approximately 43 days

    Cmax of ABBV-932

  2. Time to Cmax (Tmax) of ABBV-932

    Time frame: Up to approximately 43 days

    Tmax of ABBV-932

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

    Time frame: Up to approximately 43 days

    Ctrough of ABBV-932

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

    Time frame: Up to approximately 43 days

    AUCtau of ABBV-932

  5. Maximum Plasma Concentration (Cmax) of DCAR

    Time frame: Up to approximately 43 days

    Cmax of DCAR

  6. Time to Cmax (Tmax) of DCAR

    Time frame: Up to approximately 43 days

    Tmax of DCAR

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

    Time frame: Up to approximately 43 days

    Ctrough of DCAR

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

    Time frame: Up to approximately 43 days

    AUCtau of DCAR

  9. Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)

    Time frame: Up to approximately 43 days

    Cmax of DDCAR

  10. Time to Cmax (Tmax) of DDCAR

    Time frame: Up to approximately 43 days

    Tmax of DDCAR

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

    Time frame: Up to approximately 43 days

    Ctrough of DDCAR

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

    Time frame: Up to approximately 43 days

    AUCtau of DDCAR

  13. Number of Participants Experiencing Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Chinese Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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