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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.

Tracking Information
First Submitted Date  ICMJE October 13, 2010
First Posted Date  ICMJE October 19, 2010
Last Update Posted Date May 20, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Maximum plasma concentration (Cmax) of ertugliflozin for the Single Dose Cohort [ Time Frame: Up to Day 4 of each treatment period ]
  • 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 ]
  • 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 ]
  • AUC from Hour 0 to infinity (AUCinf) for ertugliflozin for the Single Dose Cohort [ Time Frame: Up to Day 4 of each treatment period ]
  • Ertugliflozin half life (t1/2) for the Single Dose Cohort [ Time Frame: Up to Day 4 of each treatment period ]
  • Apparent clearance (CL/F) of ertugliflozin for the Single Dose Cohort [ Time Frame: Up to Day 4 of each treatment period ]
  • Apparent volume of distribution (Vz/F) for the Single Dose Cohort [ Time Frame: Up to Day 4 of each treatment period ]
  • 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 ]
  • 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) ]
  • 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 ]
  • Urinary Glucose Excretion over 24 hours for the Single Dose Cohort [ Time Frame: Up to 24 hours postdose (Up to Day 2) ]
  • Cmax of ertugliflozin for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • Tmax of ertugliflozin for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • AUClast for ertugliflozin for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • AUCinf for ertugliflozin for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • t1/2 for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • CL/F of ertugliflozin for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • Vz/F for the Multiple Dose Cohort [ Time Frame: Up to Day 10 ]
  • Rac for the Single Dose Cohort [ Time Frame: Up to Day 10 ]
  • 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) ]
  • Number of participants who discontinued study drug due to an AE for the Multiple Dose Cohort [ Time Frame: Up to Day 7 ]
  • Urinary Glucose Excretion over 24 hours for the Multiple Dose Cohort [ Time Frame: Up to 24 hours postdose (Up to Day 8) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2010)
  • Pharmacokinetic Endpoints: Single and Multiple-Dose PK of PF-04971729 in Japanese healthy subjects. [ Time Frame: 72 hours post last dose ]
  • Safety and tolerability endpoints: Adverse event monitoring, laboratory values, cardiovascular monitoring in Japanese healthy subjects [ Time Frame: 72 hours post last dose ]
  • Pharmacodynamic Endpoints: 24-hour urinary glucose excretion in Japanese healthy subjects [ Time Frame: 24 hours post last dose ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2010)
  • Pharmacokinetic Endpoints: Single Dose PK of PF-04971729 in Western healthy subjects [ Time Frame: 72 hours post dose ]
  • Safety and tolerability endpoints: Adverse event monitoring, laboratory values, cardiovascular monitoring in Western healthy subjects [ Time Frame: 72 hours post dose ]
  • Pharmacodynamic Endpoints: 24-hour urinary glucose excretion in Western healthy subjects [ Time Frame: 24 hours post dose ]
  • Compare the pharmacokinetics and pharmacodynamics of single doses of PF-04971729 in Japanese and Western healthy subjects [ Time Frame: 72 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo
  • 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.
    Intervention: Drug: Ertugliflozin
  • 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.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01223339
Other Study ID Numbers  ICMJE 8835-041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP