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) (MAD)

March 14, 2025 updated by: AbbVie

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Collaborative Neuroscience Research CNS /ID# 260270
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Acpru /Id# 255945
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute Marlton Site /ID# 260271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A, ABBV-932
Participants will receive ABBV-932 once daily (QD) for 14 days.
Drug: ABBV-932
Capsule; oral
Experimental: Part A, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 14 days.
Drug: Placebo for ABBV-932
Capsule; oral
Experimental: Part B, ABBV-932
Participants will receive ABBV-932 QD for 28 days.
Drug: ABBV-932
Capsule; oral
Experimental: Part B, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 28 days.
Drug: Placebo for ABBV-932
Capsule; oral
Experimental: Part C, ABBV-932
Participants will receive ABBV-932 QD for 28 days.
Drug: ABBV-932
Capsule; oral
Experimental: Part C, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 28 days.
Drug: Placebo for ABBV-932
Capsule; oral
Experimental: Part D, ABBV-932
Participants will receive ABBV-932 QD for 42 days.
Drug: ABBV-932
Capsule; oral
Experimental: Part D, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 42 days.
Drug: Placebo for ABBV-932
Capsule; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to Day 28
Cmax will be assessed.
Up to Day 28
Time to Cmax (Tmax)
Time Frame: Up to Day 28
Tmax will be assessed.
Up to Day 28
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
Time Frame: Up to Day 28
Ctrough will be assessed.
Up to Day 28
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.
Up to Day 28
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.
Baseline to Day 129

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Actual)

March 4, 2025

Study Completion (Actual)

March 4, 2025

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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