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Completed

NCT Number: NCT00989079

A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.

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Key information

Conditions

Type 2 Diabetes Mellitus 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

All sexes

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 and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Treatment and study plan

Ertugliflozin

Drug

Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.

Placebo to Ertugliflozin

Drug

Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution

Primary outcomes

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

    Time frame: Up to Day 10 of each dosing period

  2. Number of Participants Discontinuing Study Drug Due to an AE

    Time frame: Up to Day 8 of each dosing period

  3. Change from baseline in 24-hour urinary glucose excretion

    Time frame: Baseline and 24 hours

  4. Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin

    Time frame: Up to Day 4 of each treatment period

  5. 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 Day 4 of each treatment period

  6. Maximum plasma concentration (Cmax) of ertugliflozin

    Time frame: Up to Day 4 of each treatment period

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

    Time frame: Up to Day 4 of each treatment period

  8. Ertugliflozin half life (t1/2)

    Time frame: Up to Day 4 of each treatment period

  9. Apparent clearance (CL/F) after a single dose of ertugliflozin

    Time frame: Up to Day 4 of each treatment period

  10. Apparent volume of distribution (Vz/F)

    Time frame: Up to Day 4 of each treatment period

Secondary outcomes

  1. Urinary glucose excretion over 72 hours

    Time frame: Up to 72 hours of each dosing period

  2. Change from baseline in 24-hour weighted mean glucose

    Time frame: Baseline and 24 hours

  3. Inhibition of glucose reabsorption

    Time frame: Up to 24 hours of each dosing period

  4. Renal clearance (CLr) of Ertugliflozin

    Time frame: Up to 24 hours of each dosing period

  5. Urinary recovery of Ertugliflozin

    Time frame: Up to 24 hours of each dosing period

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Phase 1 Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of PF-04971729 After Administration of Single Escalating Oral Doses Under Fed and Fasted Conditions in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 2, 2009
Registry last updated
May 29, 2020

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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