A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01018823
First received: November 23, 2009
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.


Condition Intervention Phase
Healthy Volunteer
Drug: Ertugliflozin
Drug: Placebo to Ertugliflozin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects

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 28 days postdose (Up to 42 days) ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to 14 days ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Ertugliflozin half life (t1/2) [ Time Frame: Up to 17 Days ] [ Designated as safety issue: No ]
  • Apparent clearance (CL/F) after a single dose of ertugliflozin [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs]) [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hour weighted mean glucose [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hour urinary glucose excretion [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hour plasma C-peptide [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
  • Inhibition of glucose reabsorption [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Baseline and Day 14 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]
  • Trough concentration of serum intact parathyroid hormone (Ctrough) [ Time Frame: Up to 17 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertugliflozin 1 mg
Ertugliflozin 1 mg, oral, once daily for 14 days
Drug: Ertugliflozin
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
Other Names:
  • PF-04971729
  • MK-8835
Experimental: Ertugliflozin up to 5 mg
Ertugliflozin up to 5 mg, oral, once daily for 14 days
Drug: Ertugliflozin
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
Other Names:
  • PF-04971729
  • MK-8835
Experimental: Ertugliflozin up to 25 mg
Ertugliflozin up to 25 mg, oral, once daily for 14 days
Drug: Ertugliflozin
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
Other Names:
  • PF-04971729
  • MK-8835
Experimental: Ertugliflozin up to 100 mg
Ertugliflozin up to 100 mg, once daily for 14 days
Drug: Ertugliflozin
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
Other Names:
  • PF-04971729
  • MK-8835
Placebo Comparator: Placebo
Placebo to Ertugliflozin once daily for 14 days
Drug: Placebo to Ertugliflozin
Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast

Detailed Description:

To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.

  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 between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

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).

Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL

  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: NCT01018823

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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: NCT01018823     History of Changes
Other Study ID Numbers: 8835-037
Study First Received: November 23, 2009
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 30, 2015