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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; Generalized Anxiety Disorder (GAD)
• Intervention / Treatment: Drug: Placebo; Drug: ABBV-932

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Gedeon Richter Plc.
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): June 6, 2024
• Study Completion (Estimated): June 6, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder (GAD); ABBV-932
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID 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