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)

AbbVie72 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers Generalized Anxiety Disorder (GAD)Bipolar Disorder (BPD)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Collaborative Neuroscience Research CNS /ID# 260270

Los Alamitos, California, United States

Acpru /Id# 255945

Grayslake, Illinois, United States

Hassman Research Institute Marlton Site /ID# 260271

Marlton, New Jersey, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax)

Cmax will be assessed.

Time frame: Up to Day 28

Time to Cmax (Tmax)

Tmax will be assessed.

Time frame: Up to Day 28

Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)

Ctrough will be assessed.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to Day 129