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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Generalized Anxiety Disorder (GAD) Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: ABBV-932

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

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Oral Capsule

Part 1: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Capsule

Part 2: Sequence 1

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.

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Oral Capsule

Part 2: Sequence 2

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.

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Oral Capsule

Part 3: Japanese Participants: ABBV-932

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

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Oral Capsule

Part 3: Japanese Participants: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Capsule

Part 3: Han-Chinese Participants: ABBV-932

Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Group Type EXPERIMENTAL

ABBV-932

Intervention Type DRUG

Oral Capsule

Interventions

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ABBV-932

Oral Capsule

Intervention Type DRUG

Placebo

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes