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A Study to Evaluate Adverse Events ABBV-932 and How Oral ABBV-932 Capsules Move Through the Body in Healthy Adults and Participants With Generalized Anxiety Disorder (GAD)

Primary Purpose

Healthy Volunteers Patients With Generalized Anxiety Disorder (GAD)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABBV-932
Placebo for ABBV-932
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers Patients With Generalized Anxiety Disorder (GAD) focused on measuring ABBV-932

Eligibility Criteria

18 Months - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. For healthy volunteer cohort: Individuals between 18 and 65 years of age inclusive at the time of screening. For patients with generalized anxiety disorder (GAD) cohort(s): Patients with GAD between 18 and 65 years of age, inclusive at time of screening meet the following criteria: Patients with DSM-5 Primary diagnosis of GAD as confirmed by MINI, and a HAM-A score ≥ 15 (at least moderate anxiety) and CGI-Severity Score ≥ 3 (mildly ill) at screening. Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. 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. History of major depressive episode within the past 3-months. Lifetime history of psychiatric illness meeting DSM-5-TR criteria (except for GAD and MDD). History of clinically significant substance use disorder (meets DSM-5-TR criteria) in the past 6-months.

Sites / Locations

  • Acpru /Id# 255945Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1, ABBV-932

Part 1, Placebo for ABBV-932

Part 2, ABBV-932

Placebo for ABBV-932

Arm Description

Participants will receive ABBV-932 once daily (QD) for 14 days.

Participants will receive placebo for ABBV-932 QD for 14 days.

Participants will receive ABBV-932 QD for 28 days.

Participants will receive placebo for ABBV-932 QD for 28 days.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)
Cmax will be assessed.
Time to Cmax (Tmax)
Tmax will be assessed.
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
Ctrough will be assessed.
Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
AUCtau will be assessed.
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.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
September 20, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT06024239
Brief Title
A Study to Evaluate Adverse Events ABBV-932 and How Oral ABBV-932 Capsules Move Through the Body in Healthy Adults and Participants With Generalized Anxiety Disorder (GAD)
Official Title
A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects and Patients With Generalized Anxiety Disorder (GAD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
March 12, 2025 (Anticipated)
Study Completion Date
March 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers Patients With Generalized Anxiety Disorder (GAD)
Keywords
ABBV-932

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1, ABBV-932
Arm Type
Experimental
Arm Description
Participants will receive ABBV-932 once daily (QD) for 14 days.
Arm Title
Part 1, Placebo for ABBV-932
Arm Type
Experimental
Arm Description
Participants will receive placebo for ABBV-932 QD for 14 days.
Arm Title
Part 2, ABBV-932
Arm Type
Experimental
Arm Description
Participants will receive ABBV-932 QD for 28 days.
Arm Title
Placebo for ABBV-932
Arm Type
Experimental
Arm Description
Participants will receive placebo for ABBV-932 QD for 28 days.
Intervention Type
Drug
Intervention Name(s)
ABBV-932
Intervention Description
Capsule; oral
Intervention Type
Drug
Intervention Name(s)
Placebo for ABBV-932
Intervention Description
Capsule; oral
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Description
Cmax will be assessed.
Time Frame
Up to Day 28
Title
Time to Cmax (Tmax)
Description
Tmax will be assessed.
Time Frame
Up to Day 28
Title
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
Description
Ctrough will be assessed.
Time Frame
Up to Day 28
Title
Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
Description
AUCtau will be assessed.
Time Frame
Up to Day 28
Title
Number of Participants with Adverse Events (AEs)
Description
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 115

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. For healthy volunteer cohort: Individuals between 18 and 65 years of age inclusive at the time of screening. For patients with generalized anxiety disorder (GAD) cohort(s): Patients with GAD between 18 and 65 years of age, inclusive at time of screening meet the following criteria: Patients with DSM-5 Primary diagnosis of GAD as confirmed by MINI, and a HAM-A score ≥ 15 (at least moderate anxiety) and CGI-Severity Score ≥ 3 (mildly ill) at screening. Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal. 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. History of major depressive episode within the past 3-months. Lifetime history of psychiatric illness meeting DSM-5-TR criteria (except for GAD and MDD). History of clinically significant substance use disorder (meets DSM-5-TR criteria) in the past 6-months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Acpru /Id# 255945
City
Grayslake
State/Province
Illinois
ZIP/Postal Code
60030
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-893
Description
Related Info

Learn more about this trial

A Study to Evaluate Adverse Events ABBV-932 and How Oral ABBV-932 Capsules Move Through the Body in Healthy Adults and Participants With Generalized Anxiety Disorder (GAD)

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