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

June 27, 2024 updated by: AbbVie

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801-2658
        • Anaheim Clinical Trials LLC /ID# 254178
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Acpru /Id# 249639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: ABBV-932
Participants will receive ABBV-932 on Day 1 and followed for 30 days.
Drug: ABBV-932
Oral Capsule
Placebo Comparator: Part 1: Placebo
Participants will receive placebo on Day 1 and followed for 30 days.
Drug: Placebo
Oral Capsule
Experimental: Part 2: Sequence 1
Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days.
Drug: ABBV-932
Oral Capsule
Experimental: Part 2: Sequence 2
Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days.
Drug: ABBV-932
Oral Capsule
Experimental: Part 3: Japanese Participants: ABBV-932
Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.
Drug: ABBV-932
Oral Capsule
Placebo Comparator: Part 3: Japanese Participants: Placebo
Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Drug: Placebo
Oral Capsule
Experimental: Part 3: Han-Chinese Participants: ABBV-932
Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Drug: ABBV-932
Oral Capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of ABBV-932
Time Frame: Up to approximately 5 days
Cmax of ABBV-932.
Up to approximately 5 days
Time to Cmax (Tmax) of ABBV-932
Time Frame: Up to approximately 5 days
Tmax of ABBV-932.
Up to approximately 5 days
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.
Up to approximately 5 days
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.
Up to approximately 5 days
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.
Up to approximately 5 days
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.
Up to approximately 5 days
Maximum Plasma Concentration (Cmax) of DCAR
Time Frame: Up to approximately 5 days
Cmax of DCAR.
Up to approximately 5 days
Time to Cmax (Tmax) of DCAR
Time Frame: Up to approximately 5 days
Tmax of DCAR.
Up to approximately 5 days
Terminal Phase Elimination Rate Constant (Beta) of DCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination rate constant (beta) of DCAR.
Up to approximately 5 days
Terminal Phase Elimination Half-Life (t1/2) of DCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination half-life of DCAR.
Up to approximately 5 days
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.
Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
Time Frame: Up to approximately 5 days
AUCinf of DCAR.
Up to approximately 5 days
Maximum Plasma Concentration (Cmax) of DDCAR
Time Frame: Up to approximately 5 days
Cmax of DDCAR.
Up to approximately 5 days
Time to Cmax (Tmax) of DDCAR
Time Frame: Up to approximately 5 days
Tmax of DDCAR.
Up to approximately 5 days
Terminal Phase Elimination Rate Constant (Beta) of DDCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination rate constant (beta) of DDCAR.
Up to approximately 5 days
Terminal Phase Elimination Half-Life (t1/2) of DDCAR
Time Frame: Up to approximately 5 days
Terminal phase elimination half-life of DDCAR.
Up to approximately 5 days
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.
Up to approximately 5 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
Time Frame: Up to approximately 5 days
AUCinf of DDCAR.
Up to approximately 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gedeon Richter Plc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M23-889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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