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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07219017 | A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants | PHASE1 | COMPLETED | 8 | — | — | Oct 15, 2025 | Dec 9, 2025 | Jan 5, 2026 | 1 | United States |
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...