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

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01127308

Collaborator

Pfizer (Industry)

Enrollment

Arm

Duration (Days)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus (T2DM)	Drug: Ertugliflozin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]Ertugliflozin Single dose - oral dosing suspension	Drug: Ertugliflozin Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin

Arm

Intervention/Treatment

Experimental: [14C]Ertugliflozin

Single dose - oral dosing suspension

Drug: Ertugliflozin

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

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:

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