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This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C]-AZD4205.
Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME properties of AZD4205 by analyzing blood, urine and feces collected during the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-AZD4205 | Experimental | A single dose of [14C]-AZD4205 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-AZD4205, single 50 mg oral dose administrated on day 1 | Drug | Each subject will receive 50 mg AZD4205 oral solution (free base equivalent) containing a nominal dose of 15 µCi [14C]- radiolabelled AZD4205 as a single administration . |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of radioactive dose recovered in urine and faeces and total percentage | To evaluate the percentage of radioactive dose of [14C] radiolabelled AZD4205 recovered in urine, feces, and in total | Up to 57 days |
| Provide samples for subsequent studies | Provide samples for subsequent studies to characterize the metabolism of [14C]AZD4205 | Up to 57 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf) for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting AUC(0-inf) | Up to 57 days |
| AUC(0-t) for [14C] radioactivity in plasma and whole blood |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events, and serious adverse events | To assess the safety and tolerability of a single dose of AZD4205 in healthy adult male subjects. | Up to 57 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Royce Morrison | Pharmaron CPC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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To determine AZD4205 plasma concentrations and the resulting AUC(0-t)
| Up to 57 days |
| Cmax for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting Cmax | Up to 57 days |
| tmax for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting tmax | Up to 57 days |
| tlag for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting tlag | Up to 57 days |
| t1/2 for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting t1/2 | Up to 57 days |
| λz for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting λz | Up to 57 days |
| CL/F for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting CL/F | Up to 57 days |
| Vss/F for [14C] radioactivity in plasma and whole blood | To determine AZD4205 plasma concentrations and the resulting Vss/F | Up to 57 days |
| Distribution of total radioactivity in blood | To compare disposition of drug-related total radioactivity in whole blood to that in plasma | Up to 57 days |
| D012959 |
| Socioeconomic Factors |