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

NCT05738850 | Completed Phase 1 FDA Drug

• 1 other identifier: M23-889
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Generalized Anxiety Disorder (GAD); Healthy Participants

Keywords

Generalized Anxiety Disorder (GAD); ABBV-932

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (7)

Part 1: ABBV-932

EXPERIMENTAL

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

Drug: ABBV-932

Part 1: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2: Sequence 1

EXPERIMENTAL

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

Part 2: Sequence 2

EXPERIMENTAL

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

Part 3: Japanese Participants: ABBV-932

EXPERIMENTAL

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

Drug: ABBV-932

Part 3: Japanese Participants: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 3: Han-Chinese Participants: ABBV-932

EXPERIMENTAL

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

Drug: ABBV-932

Interventions

ABBV-932 DRUG

Oral Capsule

Part 1: ABBV-932; Part 2: Sequence 1; Part 2: Sequence 2; Part 3: Han-Chinese Participants: ABBV-932; Part 3: Japanese Participants: ABBV-932

Placebo DRUG

Oral Capsule

Part 1: Placebo; Part 3: Japanese Participants: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AbbVie: lead
• Gedeon Richter Plc.: collaborator

Study Sites (2)

Anaheim Clinical Trials LLC /ID# 254178

Anaheim, California, 92801-2658, United States

Location

Acpru /Id# 249639

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: February 15, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)