Skip to main content
OpenTrials
Completed

NCT Number: NCT05738850

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Generalized Anxiety Disorder (GAD) Anxiety Disorders Generalized Anxiety Disorder Healthy Participants Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials LLC /ID# 254178, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Placebo

Drug

Oral Capsule

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-932

    Time frame: Up to approximately 5 days

    Cmax of ABBV-932.

  2. Time to Cmax (Tmax) of ABBV-932

    Time frame: Up to approximately 5 days

    Tmax of ABBV-932.

  3. Terminal Phase Elimination Rate Constant (Beta) of ABBV-932

    Time frame: Up to approximately 5 days

    Terminal phase elimination rate constant (beta) of ABBV-932.

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-932

    Time frame: Up to approximately 5 days

    Terminal phase elimination half-life of ABBV-932.

  5. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932

    Time frame: Up to approximately 5 days

    AUCt of ABBV-932.

  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932

    Time frame: Up to approximately 5 days

    AUCinf of ABBV-932.

  7. Maximum Plasma Concentration (Cmax) of DCAR

    Time frame: Up to approximately 5 days

    Cmax of DCAR.

  8. Time to Cmax (Tmax) of DCAR

    Time frame: Up to approximately 5 days

    Tmax of DCAR.

  9. Terminal Phase Elimination Rate Constant (Beta) of DCAR

    Time frame: Up to approximately 5 days

    Terminal phase elimination rate constant (beta) of DCAR.

  10. Terminal Phase Elimination Half-Life (t1/2) of DCAR

    Time frame: Up to approximately 5 days

    Terminal phase elimination half-life of DCAR.

  11. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR

    Time frame: Up to approximately 5 days

    AUCt of DCAR.

  12. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR

    Time frame: Up to approximately 5 days

    AUCinf of DCAR.

  13. Maximum Plasma Concentration (Cmax) of DDCAR

    Time frame: Up to approximately 5 days

    Cmax of DDCAR.

  14. Time to Cmax (Tmax) of DDCAR

    Time frame: Up to approximately 5 days

    Tmax of DDCAR.

  15. Terminal Phase Elimination Rate Constant (Beta) of DDCAR

    Time frame: Up to approximately 5 days

    Terminal phase elimination rate constant (beta) of DDCAR.

  16. Terminal Phase Elimination Half-Life (t1/2) of DDCAR

    Time frame: Up to approximately 5 days

    Terminal phase elimination half-life of DDCAR.

  17. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR

    Time frame: Up to approximately 5 days

    AUCt of DDCAR.

  18. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR

    Time frame: Up to approximately 5 days

    AUCinf of DDCAR.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Gedeon Richter Plc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2023
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.