Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants

AbbVie

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Generalized Anxiety Disorder (GAD)

Treatments

Drug: ABBV-932

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05738850

M23-889

Details and patient eligibility

About

The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.

Enrollment

104 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Parts 1 and 2: Healthy individuals with body-mass index (BMI) >= 18.0 to <= 32.0 kg/m2, rounded to the tenths decimal.
Part 3: Healthy Japanese, Han Chinese individuals with BMI >= 18.0 to <= 30.0 kg/m2, rounded to the tenths decimal.
Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ECG.

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

Sequential Assignment

Masking

Quadruple Blind

104 participants in 7 patient groups, including a placebo group

Part 1: ABBV-932

Experimental group

Description:

Participants will receive ABBV-932 on Day 1 and followed for 30 days.

Treatment:

Drug: ABBV-932

Part 1: Placebo

Placebo Comparator group

Description:

Participants will receive placebo on Day 1 and followed for 30 days.

Treatment:

Drug: Placebo

Part 2: Sequence 1

Experimental group

Description:

Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.

Treatment:

Drug: ABBV-932

Part 2: Sequence 2

Experimental group

Description:

Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.

Treatment:

Drug: ABBV-932

Part 3: Japanese Participants: ABBV-932

Experimental group

Description:

Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.

Treatment:

Drug: ABBV-932

Part 3: Japanese Participants: Placebo

Placebo Comparator group

Description:

Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.