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)

AbbVie

Status and phase: Completed; Phase 1

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

Treatments: Drug: ABBV-932; Drug: Placebo for ABBV-932

Study type: Interventional

Funder types: Industry

Identifiers

NCT06024239

M23-893

Details and patient eligibility

About

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).

Enrollment: 72 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 8 patient groups

Part A, ABBV-932

Experimental group

Description:

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

Treatment:

Drug: ABBV-932

Part A, Placebo for ABBV-932

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-932

Part B, ABBV-932

Experimental group

Description:

Participants will receive ABBV-932 QD for 28 days.

Treatment:

Drug: ABBV-932

Part B, Placebo for ABBV-932

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-932

Part C, ABBV-932

Experimental group

Description:

Participants will receive ABBV-932 QD for 28 days.

Treatment:

Drug: ABBV-932

Part C, Placebo for ABBV-932

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-932

Part D, ABBV-932

Experimental group

Description:

Participants will receive ABBV-932 QD for 42 days.

Treatment:

Drug: ABBV-932

Part D, Placebo for ABBV-932

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-932