A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
- Registration Number
- NCT01127308
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
Exclusion Criteria
- Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]Ertugliflozin Ertugliflozin Single dose - oral dosing suspension
- Primary Outcome Measures
Name Time Method Ertugliflozin half life (t1/2) Up to 7 Days Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi). Up to 7 Days AUC from Hour 0 to infinity (AUCinf) for ertugliflozin Up to 7 Days Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin Up to 7 Days Amount of Ertugliflozin and metabolites in plasma, urine, and feces 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 Maximum plasma concentration (Cmax) of ertugliflozin Up to 7 Days Number of Participants Experiencing an Adverse Event (AE) Up to 7 Days
- Secondary Outcome Measures
Name Time Method