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)
Healthy Volunteers Patients With Generalized Anxiety Disorder (GAD)
About this trial
This is an interventional basic science trial for Healthy Volunteers Patients With Generalized Anxiety Disorder (GAD) focused on measuring ABBV-932
Eligibility 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.
Sites / Locations
- Acpru /Id# 255945Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Part 1, ABBV-932
Part 1, Placebo for ABBV-932
Part 2, ABBV-932
Placebo for ABBV-932
Participants will receive ABBV-932 once daily (QD) for 14 days.
Participants will receive placebo for ABBV-932 QD for 14 days.
Participants will receive ABBV-932 QD for 28 days.
Participants will receive placebo for ABBV-932 QD for 28 days.