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

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.

Timeline

Start

2010-06

Primary completion

2010-07

Completion

2010-07

Publications

• 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.
• 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.

Drugs

Indications