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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[14C]Ertugliflozin

Single dose - oral dosing suspension

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Interventions

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Ertugliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes