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)

NCT06024239 | Completed Phase 1 FDA Drug

• 1 other identifier: M23-893
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax)

  Cmax will be assessed.

  Up to Day 28

• Time to Cmax (Tmax)

  Tmax will be assessed.

  Up to Day 28

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

  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)

  AUCtau will be assessed.

  Up to Day 28

• Number of Participants with Adverse Events (AEs)

  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

Study Arms (8)

Part A, ABBV-932

EXPERIMENTAL

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

Drug: ABBV-932

Part A, Placebo for ABBV-932

EXPERIMENTAL

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

Drug: Placebo for ABBV-932

Part B, ABBV-932

EXPERIMENTAL

Participants will receive ABBV-932 QD for 28 days.

Drug: ABBV-932

Part B, Placebo for ABBV-932

EXPERIMENTAL

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

Drug: Placebo for ABBV-932

Part C, ABBV-932

EXPERIMENTAL

Participants will receive ABBV-932 QD for 28 days.

Drug: ABBV-932

Part C, Placebo for ABBV-932

EXPERIMENTAL

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

Drug: Placebo for ABBV-932

Part D, ABBV-932

EXPERIMENTAL

Participants will receive ABBV-932 QD for 42 days.

Drug: ABBV-932

Part D, Placebo for ABBV-932

EXPERIMENTAL

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

Drug: Placebo for ABBV-932

Interventions

ABBV-932 DRUG

Capsule; oral

Part A, ABBV-932; Part B, ABBV-932; Part C, ABBV-932; Part D, ABBV-932

Placebo for ABBV-932 DRUG

Capsule; oral

Part A, Placebo for ABBV-932; Part B, Placebo for ABBV-932; Part C, Placebo for ABBV-932; Part D, Placebo for ABBV-932

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Collaborative Neuroscience Research CNS /ID# 260270

Los Alamitos, California, 90720, United States

Location

Acpru /Id# 255945

Grayslake, Illinois, 60030, United States

Location

Hassman Research Institute Marlton Site /ID# 260271

Marlton, New Jersey, 08053, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Generalized Anxiety Disorder; Bipolar Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 6, 2023
• Study Start: August 31, 2023
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)