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Completed

NCT Number: NCT06024239

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder (GAD), and participants with bipolar disorder (BPD).

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Key information

Conditions

Healthy Volunteers Anxiety Disorders Bipolar Disorder Bipolar Disorder (BPD) Bipolar and Related Disorders Generalized Anxiety Disorder Generalized Anxiety Disorder (GAD) Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Research CNS /ID# 260270, Los Alamitos, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • For healthy volunteer cohort:

-- Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal.

  • For participants with generalized anxiety disorder (GAD) or bipolar disorder (BPD)
  • Participants with GAD or BPD (as confirmed by MINI) meet participant psychiatric history criteria described in the protocol.

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.

Treatment and study plan

ABBV-932

Drug

Capsule; oral

Placebo for ABBV-932

Drug

Capsule; oral

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 28

    Cmax will be assessed.

  2. Time to Cmax (Tmax)

    Time frame: Up to Day 28

    Tmax will be assessed.

  3. Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)

    Time frame: Up to Day 28

    Ctrough will be assessed.

  4. Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)

    Time frame: Up to Day 28

    AUCtau will be assessed.

  5. Number of Participants with Adverse Events (AEs)

    Time frame: Baseline to Day 129

    An adverse event (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 Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Subjects With Generalized Anxiety Disorder (GAD) and Subjects With Bipolar Disorder

Acronym: MAD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 6, 2023
Registry last updated
Mar 17, 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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