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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A, ABBV-932 |
Participants will receive ABBV-932 once daily (QD) for 14 days. |
|
|
Experimental Part A, Placebo for ABBV-932 |
Participants will receive placebo for ABBV-932 QD for 14 days. |
|
|
Experimental Part B, ABBV-932 |
Participants will receive ABBV-932 QD for 28 days. |
|
|
Experimental Part B, Placebo for ABBV-932 |
Participants will receive placebo for ABBV-932 QD for 28 days. |
|
|
Experimental Part C, ABBV-932 |
Participants will receive ABBV-932 QD for 28 days. |
|
|
Experimental Part C, Placebo for ABBV-932 |
Participants will receive placebo for ABBV-932 QD for 28 days. |
|
|
Experimental Part D, ABBV-932 |
Participants will receive ABBV-932 QD for 42 days. |
|
|
Experimental Part D, Placebo for ABBV-932 |
Participants will receive placebo for ABBV-932 QD for 42 days. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- AbbVie
