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

Primary Purpose

Generalized Anxiety Disorder (GAD), Healthy Participants

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

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder (GAD) focused on measuring Generalized Anxiety Disorder (GAD), ABBV-932

Eligibility Criteria

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

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.

Sites / Locations

  • Anaheim Clinical Trials LLC /ID# 254178Recruiting
  • Acpru /Id# 249639Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1: ABBV-932

Part 1: Placebo

Part 2: Sequence 1

Part 2: Sequence 2

Part 3: Japanese Participants: ABBV-932

Part 3: Japanese Participants: Placebo

Part 3: Han-Chinese Participants: ABBV-932

Arm Description

Participants will receive ABBV-932 on Day 1 and followed for 30 days.

Participants will receive placebo on Day 1 and followed for 30 days.

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.

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.

Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.

Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
October 5, 2023
Sponsor
AbbVie
Collaborators
Gedeon Richter Plc.
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1. Study Identification

Unique Protocol Identification Number
NCT05738850
Brief Title
Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants
Official Title
Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
February 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Gedeon Richter Plc.

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: ABBV-932
Arm Type
Experimental
Arm Description
Participants will receive ABBV-932 on Day 1 and followed for 30 days.
Arm Title
Part 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo on Day 1 and followed for 30 days.
Arm Title
Part 2: Sequence 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2: Sequence 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 3: Japanese Participants: ABBV-932
Arm Type
Experimental
Arm Description
Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.
Arm Title
Part 3: Japanese Participants: Placebo
Arm Type
Placebo Comparator
Arm Description
Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Arm Title
Part 3: Han-Chinese Participants: ABBV-932
Arm Type
Experimental
Arm Description
Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Intervention Type
Drug
Intervention Name(s)
ABBV-932
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of ABBV-932
Description
Cmax of ABBV-932.
Time Frame
Up to approximately 5 days
Title
Time to Cmax (Tmax) of ABBV-932
Description
Tmax of ABBV-932.
Time Frame
Up to approximately 5 days
Title
Terminal Phase Elimination Rate Constant (Beta) of ABBV-932
Description
Terminal phase elimination rate constant (beta) of ABBV-932.
Time Frame
Up to approximately 5 days
Title
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Description
Terminal phase elimination half-life of ABBV-932.
Time Frame
Up to approximately 5 days
Title
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
Description
AUCt of ABBV-932.
Time Frame
Up to approximately 5 days
Title
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Description
AUCinf of ABBV-932.
Time Frame
Up to approximately 5 days
Title
Maximum Plasma Concentration (Cmax) of DCAR
Description
Cmax of DCAR.
Time Frame
Up to approximately 5 days
Title
Time to Cmax (Tmax) of DCAR
Description
Tmax of DCAR.
Time Frame
Up to approximately 5 days
Title
Terminal Phase Elimination Rate Constant (Beta) of DCAR
Description
Terminal phase elimination rate constant (beta) of DCAR.
Time Frame
Up to approximately 5 days
Title
Terminal Phase Elimination Half-Life (t1/2) of DCAR
Description
Terminal phase elimination half-life of DCAR.
Time Frame
Up to approximately 5 days
Title
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR
Description
AUCt of DCAR.
Time Frame
Up to approximately 5 days
Title
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR
Description
AUCinf of DCAR.
Time Frame
Up to approximately 5 days
Title
Maximum Plasma Concentration (Cmax) of DDCAR
Description
Cmax of DDCAR.
Time Frame
Up to approximately 5 days
Title
Time to Cmax (Tmax) of DDCAR
Description
Tmax of DDCAR.
Time Frame
Up to approximately 5 days
Title
Terminal Phase Elimination Rate Constant (Beta) of DDCAR
Description
Terminal phase elimination rate constant (beta) of DDCAR.
Time Frame
Up to approximately 5 days
Title
Terminal Phase Elimination Half-Life (t1/2) of DDCAR
Description
Terminal phase elimination half-life of DDCAR.
Time Frame
Up to approximately 5 days
Title
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR
Description
AUCt of DDCAR.
Time Frame
Up to approximately 5 days
Title
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR
Description
AUCinf of DDCAR.
Time Frame
Up to approximately 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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
Anaheim Clinical Trials LLC /ID# 254178
City
Anaheim
State/Province
California
ZIP/Postal Code
92801-2658
Country
United States
Individual Site Status
Recruiting
Facility Name
Acpru /Id# 249639
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=M23-889
Description
Related Info

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

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