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

NCT00989079

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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.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

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 (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)

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Descriptive Information
Brief Title  ICMJE A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Ertugliflozin
    Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.
  • Drug: Placebo to Ertugliflozin
    Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution
Study Arms  ICMJE
  • Experimental: Cohort 1 Sequence 1
    Period 1 (fasted) Placebo ? Period 2 (fasted) ertugliflozin (E) 10 mg ? Period 3 (fasted) E 100 mg ? Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
  • Experimental: Cohort 1 Sequence 2
    Period 1 (fasted) E 0.5 mg ? Period 2 (fasted) Placebo ? Period 3 (fasted) E 100 mg ? Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
  • Experimental: Cohort 1 Sequence 3
    Period 1 (fasted) E 0.5 mg ? Period 2 (fasted) E 10 mg ? Period 3 (fasted) Placebo ? Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
  • Experimental: Cohort 2 Sequence 1
    Period 1 (fasted) Placebo ? Period 2 (fasted) E 30 mg ? Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
  • Experimental: Cohort 2 Sequence 2
    Period 1 (fasted) E 2.5 mg ? Period 2 (fasted) Placebo ? Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
  • Experimental: Cohort 2 Sequence 3
    Period 1 (fasted) E 2.5 mg ? Period 2 (fasted) E 30 mg ? Period 3 (fasted) Placebo. Each dose of study drug will be separated by a minimum of 7 days.
    Interventions:
    • Drug: Ertugliflozin
    • Drug: Placebo to Ertugliflozin
Publications * Fediuk DJ, Nucci G, Dawra VK, Cutler DL, Amin NB, Terra SG, Boyd RA, Krishna R, Sahasrabudhe V. Overview of the Clinical Pharmacology of Ertugliflozin, a Novel Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. Clin Pharmacokinet. 2020 Aug;59(8):949-965. doi: 10.1007/s40262-020-00875-1. Review.

*   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 1, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 11, 2009
Actual Primary Completion Date December 11, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
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 NCT00989079
Other Study ID Numbers  ICMJE 8835-036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL:http://engagezone.msd.com/ds_documentation.php
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 2020

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