A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Basic science
Enrollment
8actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-15 | actual | When the study began enrolling |
| Primary completion | 2025-12-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-09 | actual | The whole study's end, after follow-up |
| First posted | 2025-10-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Intervention
- Drug: ABBV-1354
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AEs)
measured Up to approximately 32 days
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements
measured Up to approximately 15 days
Change From Baseline in Electrocardiograms (ECGs)
measured Up to approximately 15 days
Number of Participants with Abnormal Change in Physical Examinations
measured Up to approximately 15 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
measured Up to approximately 15 days
Maximum observed concentration (Cmax) of ABBV-1354
measured Up to approximately 15 days
Time to Cmax (peak time, Tmax) of ABBV-1354
measured Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-1354
measured Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354
measured Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354
measured Up to approximately 15 days
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)
measured Up to approximately 15 days
Percent of ABBV-1354 excreted in the urine
measured Up to approximately 15 days
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)
measured Up to approximately 15 days
Percent of ABBV-1354 radioactivity excreted in the feces
measured Up to approximately 15 days
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