Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-1042 · 1 trial · 1 indication
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...
ABBV-1042 is an investigational small molecule drug being developed by AbbVie Inc. It is currently in Phase 1 clinical development and is being studied in healthy adult volunteers rather than in patients with a specific disease. No approved indication has been established for ABBV-1042.
ABBV-1042 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the compound.
ABBV-1042 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program currently consists of one active Phase 1 trial, with no completed trials reported.
ABBV-1042 is being evaluated in one clinical trial, NCT07222709, titled a study to assess adverse events and how oral ABBV-1042 moves through the body of healthy adult participants. The trial is active but not recruiting, is randomized, double blind, and controlled, and has enrolled 48 participants in the United States.
The Phase 1 trial of ABBV-1042, NCT07222709, enrolls healthy adult volunteers aged 18 years and older, with no restriction by sex. It is a randomized, double blind, controlled study of oral ABBV-1042 conducted in the United States, with a planned enrollment of 48 participants.