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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00989079
First received: October 1, 2009
Last updated: April 16, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 10 of each dosing period ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 8 of each dosing period ] [ Designated as safety issue: Yes ]
  • Change from baseline in 24-hour urinary glucose excretion [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve (AUC) from Time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]
  • Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]
  • Ertugliflozin half life (t1/2) [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]
  • Apparent clearance (CL/F) after a single dose of ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: Up to Day 4 of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary glucose excretion over 72 hours [ Time Frame: Up to 72 hours of each dosing period ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hour weighted mean glucose [ Time Frame: Baseline and 24 hours ] [ Designated as safety issue: No ]
  • Inhibition of glucose reabsorption [ Time Frame: Up to 24 hours of each dosing period ] [ Designated as safety issue: No ]
  • Renal clearance (CLr) of Ertugliflozin [ Time Frame: Up to 24 hours of each dosing period ] [ Designated as safety issue: No ]
  • Urinary recovery of Ertugliflozin [ Time Frame: Up to 24 hours of each dosing period ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989079

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00989079     History of Changes
Other Study ID Numbers: 8835-036
Study First Received: October 1, 2009
Last Updated: April 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Single Ascending Dose Study in healthy subjects

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 26, 2015