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

NCT01127308 | Completed Phase 1

• 1 other identifier: 8835-038
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

[14C]Ertugliflozin

EXPERIMENTAL

Single dose - oral dosing suspension

Drug: Ertugliflozin

Interventions

Ertugliflozin DRUG

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

[14C]Ertugliflozin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Pfizer: collaborator

Related Publications (2)

• 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.

  PMID: 34213819 DERIVED

• 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.

  PMID: 33813736 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ertugliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 23, 2016

Record last verified: 2016-03