A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: ABBV-1042

Study type: Interventional

Funder types: Industry

Identifiers

NCT07222709

M25-818

Details and patient eligibility

About

This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight ˃ 45 kg at the time of screening and upon initial confinement.
• 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 suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
• Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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48 participants in 6 patient groups

ABBV-1042 or Placebo-Group 1

Experimental group

Description:

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Treatment:

Drug: ABBV-1042

Drug: Placebo

ABBV-1042 or Placebo-Group 2

Experimental group

Description:

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Treatment:

Drug: ABBV-1042

Drug: Placebo

ABBV-1042 or Placebo-Group 3

Experimental group

Description:

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Treatment:

Drug: ABBV-1042

Drug: Placebo

ABBV-1042 or Placebo-Group 4

Experimental group

Description:

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Treatment:

Drug: ABBV-1042

Drug: Placebo

ABBV-1042 or Placebo-Group 5

Experimental group

Description:

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Treatment:

Drug: ABBV-1042

Drug: Placebo

ABBV-1042 or Placebo-Group 6

Experimental group

Description:

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Treatment:

Drug: ABBV-1042

Drug: Placebo