Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants
Purpose
The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.
Conditions
- Generalized Anxiety Disorder (GAD)
- Healthy Participants
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1: ABBV-932 |
Participants will receive ABBV-932 on Day 1 and followed for 30 days. |
|
|
Placebo Comparator Part 1: Placebo |
Participants will receive placebo on Day 1 and followed for 30 days. |
|
|
Experimental 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. |
|
|
Experimental 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. |
|
|
Experimental Part 3: Japanese Participants: ABBV-932 |
Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. |
|
|
Placebo Comparator Part 3: Japanese Participants: Placebo |
Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
|
|
Experimental Part 3: Han-Chinese Participants: ABBV-932 |
Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05738850
- Status
- Completed
- Sponsor
- AbbVie