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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01127308

Enrollment

Registered

2010-05-20

Start date

2010-06-30

Completion date

2010-07-31

Last updated

2016-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Absorption, Distribution, Metabolism, and Excretion, Mass Balance, Metabolic Profile, Radiolabel Study

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.

Interventions

DRUGErtugliflozin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026