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

Phase 1

Completed

• Conditions: Healthy Participants; Generalized Anxiety Disorder (GAD)
• Interventions: Drug: Placebo; Drug: ABBV-932

• Registration Number: NCT05738850
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study Start: 2023-02-15
• Study First Posted: 2023-02-22
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Placebo	Placebo	Participants will receive placebo on Day 1 and followed for 30 days.
Part 2: Sequence 2	ABBV-932	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.
Part 3: Japanese Participants: Placebo	Placebo	Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.
Part 1: ABBV-932	ABBV-932	Participants will receive ABBV-932 on Day 1 and followed for 30 days.
Part 3: Japanese Participants: ABBV-932	ABBV-932	Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days.
Part 2: Sequence 1	ABBV-932	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.
Part 3: Han-Chinese Participants: ABBV-932	ABBV-932	Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days.

Primary Outcome Measures

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

Trial Locations

Locations (2)

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

Acpru /Id# 249639; 🇺🇸 Grayslake, Illinois, United States