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

Phase 1RecruitingNCT07222709

AbbVie48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

ABBV-1042DRUG

Oral Solution

PlaceboDRUG

Oral Solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Acpru /Id# 279405

Grayslake, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Number of Participants Experiencing Adverse Events

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Time frame: Up to approximately 32 days

Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.