Clinical Trial Details
| Trial ID: | L3905 |
| Source ID: | NCT01127308 |
| Associated Drug: | Ertugliflozin |
| Title: | A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus (T2DM) |
| Interventions: | DRUG: Ertugliflozin |
| Outcome Measures: | Primary: 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 | |
| Sponsor/Collaborators: | Sponsor: Merck Sharp & Dohme LLC | Collaborators: Pfizer |
| Gender: | MALE |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 6 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2010-06 |
| Completion Date: | 2010-07 |
| Results First Posted: | |
| Last Update Posted: | 2016-03-23 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT01127308 |
