Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07222709 | A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants | PHASE1 | RECRUITING | 48 | — | — | Oct 27, 2025 | May 1, 2026 | Oct 30, 2025 | 1 | United States |
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 like systolic and diastolic blood pressure will be assessed.
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 in areas like cardiovascular, respiratory, and neurological systems will be assessed.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Cmax of ABBV-1042
Tmax of ABBV-1042
β of ABBV-1042
t1/2 of ABBV-1042
AUCt of ABBV-1042
AUCinf of ABBV-1042
| Arm | Type | Description |
|---|---|---|
| ABBV-1042 or Placebo-Group 1 | EXPERIMENTAL | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 2 | EXPERIMENTAL | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 3 | EXPERIMENTAL | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 4 | EXPERIMENTAL | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 5 | EXPERIMENTAL | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 6 | EXPERIMENTAL | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| Name | Type | Description |
|---|---|---|
| ABBV-1042 | DRUG | Oral Solution |
| Placebo | DRUG | Oral Solution |
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 hea...