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Completed

NCT Number: NCT01223339

Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)

This study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729, MK-8835) in Japanese healthy participants. The secondary objective is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin in Western healthy participants as compared to Japanese healthy participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus 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, between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Japanese subjects must have four Japanese grandparents who were born in Japan.
  • Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Asian or Polynesian subjects in Western subject groups.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of screening.
  • History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent).
  • Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
  • 12-lead ECG demonstrating QTc >450 msec at screening.
  • Subjects with ANY of the following abnormalities on safety laboratory tests):
  • Evidence of glycosuria, as defined by a positive urine dipstick test;
  • Fasting serum triglyceride >300 mg/dL;
  • Fasting LDL-cholesterol > than or equal to 190 mg/dL.
  • Fasting serum glucose >125 mg/dL.

Treatment and study plan

Ertugliflozin

Drug

Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state

Placebo

Drug

Placebo tablets to Ertugliflozin administered in the fasted state

Primary outcomes

  1. Maximum plasma concentration (Cmax) of ertugliflozin for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  2. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  3. Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  4. AUC from Hour 0 to infinity (AUCinf) for ertugliflozin for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  5. Ertugliflozin half life (t1/2) for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  6. Apparent clearance (CL/F) of ertugliflozin for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  7. Apparent volume of distribution (Vz/F) for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  8. Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac) for the Single Dose Cohort

    Time frame: Up to Day 4 of each treatment period

  9. Number of participants who experienced an adverse event (AE) for the Single Dose Cohort

    Time frame: Up to 10 days after the final dose of study drug (Up to Day 11)

  10. Number of participants who discontinued study drug due to an AE for the Single Dose Cohort

    Time frame: Up to Day 1 of each treatment period

  11. Urinary Glucose Excretion over 24 hours for the Single Dose Cohort

    Time frame: Up to 24 hours postdose (Up to Day 2)

  12. Cmax of ertugliflozin for the Multiple Dose Cohort

    Time frame: Up to Day 10

  13. Tmax of ertugliflozin for the Multiple Dose Cohort

    Time frame: Up to Day 10

  14. AUClast for ertugliflozin for the Multiple Dose Cohort

    Time frame: Up to Day 10

  15. AUCinf for ertugliflozin for the Multiple Dose Cohort

    Time frame: Up to Day 10

  16. t1/2 for the Multiple Dose Cohort

    Time frame: Up to Day 10

  17. CL/F of ertugliflozin for the Multiple Dose Cohort

    Time frame: Up to Day 10

  18. Vz/F for the Multiple Dose Cohort

    Time frame: Up to Day 10

  19. Rac for the Single Dose Cohort

    Time frame: Up to Day 10

  20. Number of participants who experienced an AE for the Multiple Dose Cohort

    Time frame: Up to 10 days after the final dose of study drug (Up to Day 17)

  21. Number of participants who discontinued study drug due to an AE for the Multiple Dose Cohort

    Time frame: Up to Day 7

  22. Urinary Glucose Excretion over 24 hours for the Multiple Dose Cohort

    Time frame: Up to 24 hours postdose (Up to Day 8)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Placebo-Controlled, Parallel Cohort, Single Dose Escalation And Multiple Dose Study In Japanese Healthy Subjects, And Open Label, Single Dose Escalation Study In Western Healthy Subjects To Investigate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2010
Registry last updated
May 20, 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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