Back to resultsA Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
Primary Purpose
Type 2 Diabetes Mellitus (T2DM)
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ertugliflozin
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus (T2DM) focused on measuring Absorption, Distribution, Metabolism, and Excretion, Mass Balance, Metabolic Profile, Radiolabel Study
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[14C]Ertugliflozin
Arm Description
Single dose - oral dosing suspension
Outcomes
Primary Outcome Measures
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
Maximum plasma concentration (Cmax) of ertugliflozin
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Ertugliflozin half life (t1/2)
Amount of Ertugliflozin and metabolites in plasma, urine, and feces
Number of Participants Experiencing an Adverse Event (AE)
Secondary Outcome Measures
Full Information
NCT ID
NCT01127308
First Posted
May 19, 2010
Last Updated
March 22, 2016
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01127308
Brief Title
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus (T2DM)
Keywords
Absorption, Distribution, Metabolism, and Excretion, Mass Balance, Metabolic Profile, Radiolabel Study
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[14C]Ertugliflozin
Arm Type
Experimental
Arm Description
Single dose - oral dosing suspension
Intervention Type
Drug
Intervention Name(s)
Ertugliflozin
Intervention Description
Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin
Primary Outcome Measure Information:
Title
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
Title
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
Title
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
Time Frame
Up to 7 Days
Title
Maximum plasma concentration (Cmax) of ertugliflozin
Time Frame
Up to 7 Days
Title
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
Time Frame
Up to 7 Days
Title
Ertugliflozin half life (t1/2)
Time Frame
Up to 7 Days
Title
Amount of Ertugliflozin and metabolites in plasma, urine, and feces
Time Frame
Up to 7 Days
Title
Number of Participants Experiencing an Adverse Event (AE)
Time Frame
Up to 7 Days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
34213819
Citation
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.
Results Reference
derived
PubMed Identifier
33813736
Citation
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.
Results Reference
derived
Learn more about this trial
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)
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