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)

Purpose

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)

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT06024239
Status
Completed
Sponsor
AbbVie

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center