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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-03-04

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers Generalized Anxiety Disorder (GAD) Bipolar Disorder (BPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A, ABBV-932

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

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Capsule; oral

Part A, Placebo for ABBV-932

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

Group Type EXPERIMENTAL

Placebo for ABBV-932

Intervention Type DRUG

Capsule; oral

Part B, ABBV-932

Participants will receive ABBV-932 QD for 28 days.

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Capsule; oral

Part B, Placebo for ABBV-932

Participants will receive placebo for ABBV-932 QD for 28 days.

Group Type EXPERIMENTAL

Placebo for ABBV-932

Intervention Type DRUG

Capsule; oral

Part C, ABBV-932

Participants will receive ABBV-932 QD for 28 days.

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Capsule; oral

Part C, Placebo for ABBV-932

Participants will receive placebo for ABBV-932 QD for 28 days.

Group Type EXPERIMENTAL

Placebo for ABBV-932

Intervention Type DRUG

Capsule; oral

Part D, ABBV-932

Participants will receive ABBV-932 QD for 42 days.

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Capsule; oral

Part D, Placebo for ABBV-932

Participants will receive placebo for ABBV-932 QD for 42 days.

Group Type EXPERIMENTAL

Placebo for ABBV-932

Intervention Type DRUG

Capsule; oral

Interventions

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ABBV-932

Capsule; oral

Intervention Type DRUG

Placebo for ABBV-932

Capsule; oral

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes