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The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-552 in healthy, male volunteers following administration of a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-552 | Experimental | Participants will receive ABBV-552 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-552 | Drug | Oral Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. | Up to approximately 30 days |
| Maximum observed concentration (Cmax) of ABBV-552 | Cmax of ABBV-552 will be assessed. | Up to approximately Day 15 |
| Time to Cmax (peak time, Tmax) of ABBV-552 | Tmax of ABBV-552 will be assessed. | Up to approximately 15 days |
| Terminal phase elimination rate constant (λz) of ABBV-552 | Terminal phase elimination rate constant (λz) of ABBV-552 will be assessed. | Up to approximately 15 days |
| Terminal phase elimination half-life (t1/2) of ABBV-552 | Terminal phase elimination half-life (t1/2) of ABBV-552 will be assessed. | 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-552 | AUCt of ABBV-552 will be assessed. | Up to approximately 15 days |
| Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552 | AUCinf of ABBV-552 will be assessed. |
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Inclusion Criteria:
- Male volunteers in general good health at Screening.
Exclusion Criteria:
- Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc /ID# 262684 | Madison | Wisconsin | 53704 | United States |
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| Up to approximately 15 days |
| Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) | Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) will be assessed. | Up to approximately 15 days |
| Percent of ABBV-552 excreted in the urine | Percent excreted = 100 × (Aeu/dose). | Up to approximately 15 days |
| Renal clearance ABBV-552 (CLr) | Renal clearance of ABBV-552 will be assessed. | Up to approximately 15 days |
| Amount of ABBV-552 excreted in the feces over the sampling period (Aef) | Amount of ABBV-552 excreted in the feces over the sampling period (Aef) will be assessed. | Up to approximately 15 days |
| Percent radioactivity excreted in the feces | Percent excreted = 100 × (Aef/dose). | Up to approximately 15 days |