A Study to Evaluate Adverse Events ABBV-932 and How Oral ABBV-932 Capsules Move Through the Body in Healthy Adults and Participants With Generalized Anxiety Disorder (GAD)
Study Details
Study Description
Brief Summary
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 and patients with Generalized Anxiety Disorder (GAD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1, ABBV-932 Participants will receive ABBV-932 once daily (QD) for 14 days. |
Drug: ABBV-932
Capsule; oral
|
| Experimental: Part 1, Placebo for ABBV-932 Participants will receive placebo for ABBV-932 QD for 14 days. |
Drug: Placebo for ABBV-932
Capsule; oral
|
| Experimental: Part 2, ABBV-932 Participants will receive ABBV-932 QD for 28 days. |
Drug: ABBV-932
Capsule; oral
|
| Experimental: Placebo for ABBV-932 Participants will receive placebo for ABBV-932 QD for 28 days. |
Drug: Placebo for ABBV-932
Capsule; oral
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) [Up to Day 28]
Cmax will be assessed.
- Time to Cmax (Tmax) [Up to Day 28]
Tmax will be assessed.
- Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough) [Up to Day 28]
Ctrough will be assessed.
- Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) [Up to Day 28]
AUCtau will be assessed.
- Number of Participants with Adverse Events (AEs) [Baseline to Day 115]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal.
-
For healthy volunteer cohort:
-
Individuals between 18 and 65 years of age inclusive at the time of screening.
-
For patients with generalized anxiety disorder (GAD) cohort(s): Patients with GAD between 18 and 65 years of age, inclusive at time of screening meet the following criteria:
-
Patients with DSM-5 Primary diagnosis of GAD as confirmed by MINI, and a HAM-A score ≥ 15 (at least moderate anxiety) and CGI-Severity Score ≥ 3 (mildly ill) at screening.
-
Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal.
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.
-
History of major depressive episode within the past 3-months.
-
Lifetime history of psychiatric illness meeting DSM-5-TR criteria (except for GAD and MDD).
-
History of clinically significant substance use disorder (meets DSM-5-TR criteria) in the past 6-months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Acpru /Id# 255945 | Grayslake | Illinois | United States | 60030 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- M23-893