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)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06024239

Acronym

MAD

Enrollment

Registered

2023-09-06

Start date

2023-08-31

Completion date

2025-03-04

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ABBV-932, Generalized Anxiety Disorder (GAD), Bipolar Disorder (BPD)

Brief summary

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).

Interventions

DRUGABBV-932

Capsule; oral

DRUGPlacebo for ABBV-932

Capsule; oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax)	Up to Day 28	Cmax will be assessed.
Time to Cmax (Tmax)	Up to Day 28	Tmax will be assessed.
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)	Up to Day 28	Ctrough will be assessed.
Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)	Up to Day 28	AUCtau will be assessed.
Number of Participants with Adverse Events (AEs)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026