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A Study of ABBV-1042 in Healthy Adults

This study is looking for healthy adults, aged 18 to 55, to help us understand a new oral solution called ABBV-1042. We want to learn about any side effects (adverse events) it might cause and how it moves through your body. Some participants will receive ABBV-1042, while others will receive a placebo (an inactive substance that looks like the study drug). We'll measure side effects, changes in vital signs (like blood pressure and heart rate), and use a scale to check for any changes in mood or thoughts of self-harm. To join, you need to be in good general health and have a Body Mass Index (BMI) between 18.0 and 32.0, and weigh over 45 kg. The study's current status is unclear.

Study design
This interventional study plans to enroll 48 healthy adult participants. It will compare the effects of ABBV-1042 oral solution with a placebo oral solution.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 32 days. Vital signs and a mood assessment will be measured for up to approximately 3 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07222709

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

Recruiting
PHASE1Ages 18–55InterventionalBasic science
AbbVie
~48 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:ABBV-1042Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Adverse Events
Measured over Up to approximately 32 days
+11 more outcomes measured

Conditions

Healthy Volunteer

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants Experiencing Adverse EventsUp to approximately 32 days

    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.

  • Number of Participants with Abnormal Change From Baseline in Vital Sign MeasurementsUp to approximately 3 days

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

  • Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)Up to approximately 3 days

    The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.

  • Number of Participants with Abnormal Change in Physical ExaminationsUp to approximately 3 days

    Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, and neurological systems will be assessed.

  • Number of Participants with Change from Baseline in Electrocardiogram (ECG)Up to approximately 3 days

    12-lead resting ECG will be recorded.

  • Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be AssessedUp to approximately 3 days

    Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  • Maximum Plasma Concentration (Cmax) of ABBV-1042Up to approximately 3 days

    Cmax of ABBV-1042

  • Time to Cmax (Tmax) of ABBV-1042Up to approximately 3 days

    Tmax of ABBV-1042

  • Apparent terminal phase elimination constant (β) of ABBV-1042Up to approximately 3 days

    β of ABBV-1042

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042Up to approximately 3 days

    t1/2 of ABBV-1042

  • Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042Up to approximately 3 days

    AUCt of ABBV-1042

  • Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042Up to approximately 3 days

    AUCinf of ABBV-1042