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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002048-54 | EudraCT Number |
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The purpose of this study is to investigate how the drug Lu AG06466 is absorbed, metabolized, and excreted from the body, for example, what the body does to the drug after swallowing a single dose.
Researchers will measure the levels of the drug and its breakdown product in each participants blood for up to 5 days after dosing. Radioactivity in urine and feces will be measured for up to 3.5 weeks after dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-Lu AG06466 | Experimental | Participants will receive a single oral dose of [14C]-Lu AG06466 on Day 1 in the fed state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-Lu AG06466 | Drug | [14C]-Lu AG06466 will be administered per schedule specified in the arm description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percent Recovery of Radioactivity in Urine | From Day 1 to Day 23 | |
| Cumulative Percent Recovery of Radioactivity in Faeces | From Day 1 to Day 23 | |
| Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces | From Day 1 to Day 23 | |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AG06466 | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 | |
| AUC0-inf of Metabolite Lu AG06988 in Plasma | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 | |
| Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 | |
| Cmax of Metabolite Lu AG0988 in Plasma | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 | |
| Time to Reach Cmax (tmax) of Lu AG06466 | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 | |
| Tmax of Metabolite Lu AG06988 | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 | |
| Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LabCorp Clinical Research Unit Ltd | Leeds | LS2 9LH | United Kingdom |
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| 0 (predose) up to 96 hours postdose on Day 1 to Day 5 |
| t1/2 of Metabolite Lu AG06988 in Plasma | 0 (predose) up to 96 hours postdose on Day 1 to Day 5 |