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The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human AME | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-EDG-7500 | Drug | Oral liquid suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance | From Day -1 through study completion (up to 19 days) | |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax | From Day 1 to study completion (up to 18 days) | |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax | From Day 1 to study completion (up to 18 days) | |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2 | From Day 1 to study completion (up to 18 days) | |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf | From Day 1 to study completion (up to 18 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite profile | From Day -1 through study completion (up to 19 days) | |
| Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements | From screening through study completion (up to 54 days) |
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Key Inclusion Criteria:
Biological males ≥ 18.0 and < 55.0 years of age at time of providing Informed Consent.
Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen.
Non-smoker
Key Exclusion Criteria:
Additional protocol defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron Clinical Pharmacology Center, Inc. | Baltimore | Maryland | 21201 | United States |
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