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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127308
• Other study ID #: 8835-038
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2010
• Last updated: March 22, 2016
• Start date: June 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).		Up to 7 Days	No
Primary	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	No
Primary	AUC from Hour 0 to infinity (AUCinf) for ertugliflozin		Up to 7 Days	No
Primary	Maximum plasma concentration (Cmax) of ertugliflozin		Up to 7 Days	No
Primary	Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin		Up to 7 Days	No
Primary	Ertugliflozin half life (t1/2)		Up to 7 Days	No
Primary	Amount of Ertugliflozin and metabolites in plasma, urine, and feces		Up to 7 Days	No
Primary	Number of Participants Experiencing an Adverse Event (AE)		Up to 7 Days	Yes