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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Ertugliflozin | Experimental | Single dose - oral dosing suspension |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertugliflozin | Drug | Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi). | Up to 7 Days | |
| Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin | Up to 7 Days | |
| AUC from Hour 0 to infinity (AUCinf) for ertugliflozin | Up to 7 Days | |
| Maximum plasma concentration (Cmax) of ertugliflozin | Up to 7 Days | |
| Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin | Up to 7 Days | |
| Ertugliflozin half life (t1/2) | Up to 7 Days | |
| Amount of Ertugliflozin and metabolites in plasma, urine, and feces | Up to 7 Days | |
| Number of Participants Experiencing an Adverse Event (AE) | Up to 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34213819 | Derived | Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2. | |
| 33813736 | Derived | Marshall JC, Liang Y, Sahasrabudhe V, Tensfeldt T, Fediuk DJ, Zhou S, Krishna R, Dawra VK, Wood LS, Sweeney K. Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure. J Clin Pharmacol. 2021 Sep;61(9):1220-1231. doi: 10.1002/jcph.1866. Epub 2021 Jun 19. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570288 | ertugliflozin |
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| D004700 | Endocrine System Diseases |