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This was an open-label, non-randomised, single-dose study in 6 healthy male subjects. Subjects attended a screening visit within 28 days before drug administration. Subjects were admitted to the clinical unit on the morning of the day before dosing (Day -1) and received a single oral administration of study drug in a fasted state on Day 1. Subjects were resident in the clinic for up to 7 days after dosing; they could be discharged sooner if a mass balance cumulative recovery of >95% was achieved, or if a mass balance cumulative recovery of >90% was achieved and <1% was collected within 2 separate, consecutive 24 h periods. At specified times during the study period, blood samples were taken and urine and faeces were collected for PK analysis. Safety assessments were also performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-LC15-0444 | Experimental | A single oral dose of [14C]-LC15-0444 50 mg , containing 4.9 MBq [14C] (batch number 110372/C/01). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-LC15-0444 | Drug | A single oral administration of [14C]-LC15-0444 50 mg, containing 4.9 MBq [14C]. Subjects in the fasted state will receive the drug as a capsule, with 240 ml of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Whole blood and plasma concentrations of total radioactivity | up to 72h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Plasma concentrations of parent drug | up to 72h post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair MBChB | Quotient Bioresearch Clinical Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LG Life Sciences | Seoul | 110-062 | South Korea |
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