A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01018823
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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).
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo to Ertugliflozin Placebo to Ertugliflozin once daily for 14 days Ertugliflozin 1 mg Ertugliflozin Ertugliflozin 1 mg, oral, once daily for 14 days Ertugliflozin up to 5 mg Ertugliflozin Ertugliflozin up to 5 mg, oral, once daily for 14 days Ertugliflozin up to 25 mg Ertugliflozin Ertugliflozin up to 25 mg, oral, once daily for 14 days Ertugliflozin up to 100 mg Ertugliflozin Ertugliflozin up to 100 mg, once daily for 14 days
- Primary Outcome Measures
Name Time Method Change from baseline in 24-hour urinary glucose excretion Baseline and Day 14 Change from baseline in 24-hour plasma C-peptide Baseline and Day 14 Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone Up to 17 days Trough concentration of serum intact parathyroid hormone (Ctrough) Up to 17 days Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone Up to 17 days Number of Participants Discontinuing Study Drug Due to an AE Up to 14 days Maximum plasma concentration (Cmax) of ertugliflozin Up to 17 days Ertugliflozin half life (t1/2) Up to 17 Days Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs]) Up to 17 days Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin Up to 17 days Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin Up to 17 days Change from baseline in 24-hour weighted mean glucose Baseline and Day 14 Change from baseline in body weight Baseline and Day 14 Apparent clearance (CL/F) after a single dose of ertugliflozin Up to 17 days Apparent volume of distribution (Vz/F) Up to 17 days Inhibition of glucose reabsorption Baseline and Day 14 Number of Participants Experiencing an Adverse Event (AE) Up to 28 days postdose (Up to 42 days)
- Secondary Outcome Measures
Name Time Method