Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-1354 · 1 trial · 1 indication
An adverse event (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.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Cmax of ABBV-1354 will be assessed.
Max of ABBV-1354 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.
AUCt of ABBV-1354 will be assessed.
AUCinf of ABBV-1354 will be assessed.
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Percent excreted = 100 × (Aeu/dose).
| Arm | Type | Description |
|---|---|---|
| ABBV-1354 | EXPERIMENTAL | Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose. |
| Name | Type | Description |
|---|---|---|
| ABBV-1354 | DRUG | Oral solution |
Inclusion Criteria: * Male participants are eligible to participate if they agree to the following from Study Day 1 and for at least 93 days after the last dose of study treatment: * Refrain from donating sperm PLUS, either: \- Practice true abstinence, defined as: Refraining from heterosexual in...
ABBV-1354 is an investigational small molecule being developed by AbbVie Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, specifically in a mass balance study to assess how the drug is absorbed, distributed, metabolized, and excreted in the body.
ABBV-1354 is being studied in healthy volunteers as part of early clinical development. The completed Phase 1 trial was a mass balance study designed to evaluate the pharmacokinetics of the drug, meaning how it is processed by the body. No specific disease indication has been reported for ABBV-1354 at this stage.
ABBV-1354 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting early-stage clinical research on this small molecule drug candidate.
ABBV-1354 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is still in early-stage testing, with one Phase 1 trial completed that enrolled healthy adult male participants.
ABBV-1354 has been studied in one clinical trial, identified as NCT07219017. This was a Phase 1 mass balance study conducted in the United States, enrolling 8 healthy adult male participants aged 18 years and older. The trial has been completed.
No alternative names for ABBV-1354 have been reported. The drug is known only by its development code ABBV-1354, which is the identifier used in clinical trial registrations and scientific literature.