Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants

Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05738850

Enrollment

104

Registered

2023-02-22

Start date

2023-02-15

Completion date

2024-05-31

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder (GAD), Healthy Participants

Keywords

Generalized Anxiety Disorder (GAD), ABBV-932

Brief summary

The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.

Interventions

DRUGABBV-932

Oral Capsule

DRUGPlacebo

Oral Capsule

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Parts 1 and 2: Healthy individuals with body-mass index (BMI) \>= 18.0 to \<= 32.0 kg/m2, rounded to the tenths decimal. * Part 3: Healthy Japanese, Han Chinese individuals with BMI \>= 18.0 to \<= 30.0 kg/m2, rounded to the tenths decimal. * Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ECG.

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Plasma Concentration (Cmax) of ABBV-932	Up to approximately 5 days	Cmax of ABBV-932.
Time to Cmax (Tmax) of ABBV-932	Up to approximately 5 days	Tmax of ABBV-932.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-932	Up to approximately 5 days	Terminal phase elimination rate constant (beta) of ABBV-932.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932	Up to approximately 5 days	Terminal phase elimination half-life of ABBV-932.
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932	Up to approximately 5 days	AUCt of ABBV-932.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932	Up to approximately 5 days	AUCinf of ABBV-932.
Maximum Plasma Concentration (Cmax) of DCAR	Up to approximately 5 days	Cmax of DCAR.
Time to Cmax (Tmax) of DCAR	Up to approximately 5 days	Tmax of DCAR.
Terminal Phase Elimination Rate Constant (Beta) of DCAR	Up to approximately 5 days	Terminal phase elimination rate constant (beta) of DCAR.
Terminal Phase Elimination Half-Life (t1/2) of DCAR	Up to approximately 5 days	Terminal phase elimination half-life of DCAR.
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR	Up to approximately 5 days	AUCt of DCAR.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR	Up to approximately 5 days	AUCinf of DCAR.
Maximum Plasma Concentration (Cmax) of DDCAR	Up to approximately 5 days	Cmax of DDCAR.
Time to Cmax (Tmax) of DDCAR	Up to approximately 5 days	Tmax of DDCAR.
Terminal Phase Elimination Rate Constant (Beta) of DDCAR	Up to approximately 5 days	Terminal phase elimination rate constant (beta) of DDCAR.
Terminal Phase Elimination Half-Life (t1/2) of DDCAR	Up to approximately 5 days	Terminal phase elimination half-life of DDCAR.
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR	Up to approximately 5 days	AUCt of DDCAR.
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR	Up to approximately 5 days	AUCinf of DDCAR.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026