Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-1042
Brief summary
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
Interventions
DRUGABBV-1042
Oral Solution
DRUGPlacebo
Oral Solution
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactABBVIE CALL CENTER
Outcome results
None listed