CClinicalTrials.gg
Sign In
CompletedNCT01127308Updated Mar 23, 2016

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

A Phase 1 interventional study of Ertugliflozin in Type 2 Diabetes Mellitus (T2DM), sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-23.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)

Keywords

  • Absorption
  • Distribution
  • Metabolism
  • and Excretion
  • Mass Balance
  • Metabolic Profile
  • Radiolabel Study
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 6 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [14C]Ertugliflozin

    Single dose - oral dosing suspension

    Drug: Ertugliflozin

Interventions

  • DrugErtugliflozin

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

06

What researchers measure

Primary outcomes

  1. Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).

    Time frame: Up to 7 Days

  2. Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin

    Time frame: Up to 7 Days

  3. AUC from Hour 0 to infinity (AUCinf) for ertugliflozin

    Time frame: Up to 7 Days

  4. Maximum plasma concentration (Cmax) of ertugliflozin

    Time frame: Up to 7 Days

  5. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin

    Time frame: Up to 7 Days

  6. Ertugliflozin half life (t1/2)

    Time frame: Up to 7 Days

  7. Amount of Ertugliflozin and metabolites in plasma, urine, and feces

    Time frame: Up to 7 Days

  8. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to 7 Days

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 34213819 ↗
  • 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. PubMed 33813736 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01127308
Lead sponsor
Merck Sharp & Dohme LLC
Collaborators
Pfizer
Responsible party
Sponsor
First posted
May 20, 2010
Start date
Jun 2010
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Mar 23, 2016

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Merck Sharp & Dohme LLC

Start the discussion