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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, ABBV-932 | Experimental | Participants will receive ABBV-932 once daily (QD) for 14 days. |
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| Part A, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 14 days. |
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| Part B, ABBV-932 | Experimental | Participants will receive ABBV-932 QD for 28 days. |
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| Part B, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 28 days. |
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| Part C, ABBV-932 | Experimental | Participants will receive ABBV-932 QD for 28 days. |
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| Part C, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 28 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-932 | Drug | Capsule; oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax will be assessed. | Up to Day 28 |
| Time to Cmax (Tmax) | Tmax will be assessed. | Up to Day 28 |
| Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough) | Ctrough will be assessed. | Up to Day 28 |
| Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) | AUCtau will be assessed. | Up to Day 28 |
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Baseline to Day 129 |
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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)
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.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research CNS /ID# 260270 | Los Alamitos | California | 90720 | United States | ||
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| Part D, ABBV-932 | Experimental | Participants will receive ABBV-932 QD for 42 days. |
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| Part D, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 42 days. |
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| Placebo for ABBV-932 | Drug | Capsule; oral |
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| Acpru /Id# 255945 |
| Grayslake |
| Illinois |
| 60030 |
| United States |
| Hassman Research Institute Marlton Site /ID# 260271 | Marlton | New Jersey | 08053 | United States |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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