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NCT Number: NCT01127308

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

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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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ertugliflozin

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. AUC from Hour 0 to infinity (AUCinf) for ertugliflozin

    Time frame: Up to 7 Days

  4. Maximum plasma concentration (Cmax) of ertugliflozin

    Time frame: Up to 7 Days

  5. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin

    Time frame: Up to 7 Days

  6. Ertugliflozin half life (t1/2)

    Time frame: Up to 7 Days

  7. Amount of Ertugliflozin and metabolites in plasma, urine, and feces

    Time frame: Up to 7 Days

  8. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to 7 Days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 20, 2010
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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