NCT01127308

A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)

An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Ertugliflozin	Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of \[14C\]ertugliflozin

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-05-20
• Last updated: 2016-03-23