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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of [14C] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] ABBV-CLS-7262 | Experimental | Participants will receive [14C] ABBV-CLS-7262 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] ABBV-CLS-7262 | 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 from last dose. |
| Maximum observed concentration (Cmax) | Cmax will be assessed. | Up to approximately Day 15 from last dose |
| Time to Cmax (peak time, Tmax) | Tmax will be assessed. | Up to approximately 15 days from last dose |
| Terminal phase elimination half-life (t1/2) | Terminal phase elimination half-life (t1/2) will be assessed. | Up to approximately 15 days from last dose |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) | AUCt will be assessed. | Up to approximately 15 days from last dose |
| Percent radioactivity excreted | Percentage total radioactivity | Up to approximately 15 days from last dose |
| Identification of metabolites excreted | Identification of the major metabolites | Up to approximately 15 days from last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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