A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Patients With Generalized Anxiety Disorder (GAD) and Patients With Schizophrenia (SCZ)

Study Overview
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Brief Summary
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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 and patients with Generalized Anxiety Disorder (GAD) and patients with schizophrenia (SCZ).

Official Title
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A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Patients With Generalized Anxiety Disorder (GAD) and Patients With Schizophrenia (SCZ)

Conditions
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Healthy Volunteers Generalized Anxiety Disorder (GAD) Schizophrenia (SCZ)

Intervention / Treatment
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* Drug: ABBV-932
* Drug: Placebo for ABBV-932


Participation Criteria
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Eligibility Criteria
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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 schizophrenia (SCZ) Participants with GAD or SCZ (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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, ABBV-932<br>Participants will receive ABBV-932 once daily (QD) for 14 days. | Drug: ABBV-932<br>* Capsule; oral<br>|
| Experimental: Part 1, Placebo for ABBV-932<br>Participants will receive placebo for ABBV-932 QD for 14 days. | Drug: Placebo for ABBV-932<br>* Capsule; oral<br>|
| Experimental: Part 2, ABBV-932<br>Participants will receive ABBV-932 QD for 28 days. | Drug: ABBV-932<br>* Capsule; oral<br>|
| Experimental: Placebo for ABBV-932<br>Participants will receive placebo for ABBV-932 QD for 28 days. | Drug: Placebo for ABBV-932<br>* Capsule; oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 115 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-932 Generalized Anxiety Disorder (GAD) Schizophrenia (SCZ)