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Trial record 1 of 1 for:    NCT01223339
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Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)

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ClinicalTrials.gov Identifier: NCT01223339
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Ertugliflozin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Dose Japanese Cohort
This will be a single dose Cohort in which Japanese healthy participants will receive 3 ascending single doses (1 mg, 5 mg, and 25 mg) of ertugliflozin or placebo through 3 dosing periods. A minimum wash out period of 7-days will be set between each dose administration.
Drug: Ertugliflozin
Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state

Drug: Placebo
Placebo tablets to Ertugliflozin administered in the fasted state

Experimental: Single dose Western cohort
This will be a single dose Cohort in which Western healthy participants will receive 3 ascending single doses (1 mg, 5 mg, and 25 mg) of ertugliflozin through 3 dosing periods. A minimum wash out period of 7-days will be set between each dose administration.
Drug: Ertugliflozin
Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state

Experimental: Multiple Dose Japanese Cohort
This will be a multiple dose Cohort in which Japanese healthy participants will receive once-daily 25 mg ertugliflozin or placebo for 7 days.
Drug: Ertugliflozin
Ertugliflozin 25 mg tablets administered once daily in the fed state for 7 days

Drug: Placebo
Placebo tablets administered once daily in the fed state for 7 days




Primary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223339


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01223339    
Other Study ID Numbers: 8835-041
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Keywords provided by Merck Sharp & Dohme Corp.:
Ertugliflozin
Japanese and Western population
pharmacokinetics
pharmacodynamics
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs