This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Number of Participants Experiencing Adverse Events — Up 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 Measurements — Up 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 Examinations — Up 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 Assessed — Up 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-1042 — Up to approximately 3 days Cmax of ABBV-1042
Time to Cmax (Tmax) of ABBV-1042 — Up to approximately 3 days Tmax of ABBV-1042
Apparent terminal phase elimination constant (β) of ABBV-1042 — Up to approximately 3 days β of ABBV-1042
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042 — Up 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-1042 — Up to approximately 3 days AUCt of ABBV-1042
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042 — Up to approximately 3 days AUCinf of ABBV-1042
Trial sites (1)
Facility
City
Region
Status
Acpru /Id# 279405
Grayslake
Illinois
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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