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

NCT01223339

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 DirectorMerck 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