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

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ClinicalTrials.gov Identifier: NCT01018823
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: Ertugliflozin Drug: Placebo to Ertugliflozin Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : December 14, 2009
Primary Completion Date : March 18, 2010
Study Completion Date : March 18, 2010
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 28 days postdose (Up to 42 days) ]
  2. Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to 14 days ]
  3. Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin [ Time Frame: Up to 17 days ]
  4. Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to 17 days ]
  5. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to 17 days ]
  6. Ertugliflozin half life (t1/2) [ Time Frame: Up to 17 Days ]
  7. Apparent clearance (CL/F) after a single dose of ertugliflozin [ Time Frame: Up to 17 days ]
  8. Apparent volume of distribution (Vz/F) [ Time Frame: Up to 17 days ]
  9. Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs]) [ Time Frame: Up to 17 days ]
  10. Change from baseline in 24-hour weighted mean glucose [ Time Frame: Baseline and Day 14 ]
  11. Change from baseline in 24-hour urinary glucose excretion [ Time Frame: Baseline and Day 14 ]
  12. Change from baseline in 24-hour plasma C-peptide [ Time Frame: Baseline and Day 14 ]
  13. Inhibition of glucose reabsorption [ Time Frame: Baseline and Day 14 ]
  14. Change from baseline in body weight [ Time Frame: Baseline and Day 14 ]
  15. Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone [ Time Frame: Up to 17 days ]
  16. Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone [ Time Frame: Up to 17 days ]
  17. Trough concentration of serum intact parathyroid hormone (Ctrough) [ Time Frame: Up to 17 days ]

Eligibility Criteria

Information from the National Library of Medicine

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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 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

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): NCT01018823


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01018823     History of Changes
Other Study ID Numbers: 8835-037
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms