Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult Chinese Participants

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-932; Drug: Placebo for ABBV-932

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024797

M25-644

Details and patient eligibility

About

This study will assess the adverse events, tolerability, and how oral doses of ABBV-932 moves through the body in healthy adult Chinese participants.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) ≥ 18.0 to ≤ 27.9 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion criteria

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, unexplained syncope, or any uncontrolled medical illness.
• History of suicidal ideation within one year prior to study treatment administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts as evidenced by answering "yes" to any suicidal behavior question (except a "yes" to the "Has subject engaged in non-suicidal self-injurious behavior" question) within the last 2 years.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups

ABBV-932 or Placebo Part A

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-932

Drug: ABBV-932

ABBV-932 or Placebo Part B

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-932

Drug: ABBV-932

ABBV-932 or Placebo Part C

Experimental group

Description:

Participants will receive oral ABBV-932 or placebo QD 42 days.

Treatment:

Drug: Placebo for ABBV-932

Drug: ABBV-932