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

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ClinicalTrials.gov Identifier: NCT00989079
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : March 18, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 10 of each dosing period ]
  2. Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 8 of each dosing period ]
  3. Change from baseline in 24-hour urinary glucose excretion [ Time Frame: Baseline and 24 hours ]
  4. 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 ]
  5. 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 ]
  6. Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ]
  7. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ]
  8. Ertugliflozin half life (t1/2) [ Time Frame: Up to Day 4 of each treatment period ]
  9. Apparent clearance (CL/F) after a single dose of ertugliflozin [ Time Frame: Up to Day 4 of each treatment period ]
  10. Apparent volume of distribution (Vz/F) [ Time Frame: Up to Day 4 of each treatment period ]

Secondary Outcome Measures :
  1. Urinary glucose excretion over 72 hours [ Time Frame: Up to 72 hours of each dosing period ]
  2. Change from baseline in 24-hour weighted mean glucose [ Time Frame: Baseline and 24 hours ]
  3. Inhibition of glucose reabsorption [ Time Frame: Up to 24 hours of each dosing period ]
  4. Renal clearance (CLr) of Ertugliflozin [ Time Frame: Up to 24 hours of each dosing period ]
  5. Urinary recovery of Ertugliflozin [ Time Frame: Up to 24 hours of each dosing period ]


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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.
  • 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)

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): NCT00989079


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00989079     History of Changes
Other Study ID Numbers: 8835-036
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016

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

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