Healthy Volunteer
Conditions
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.
Interventions
DRUGErtugliflozin
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast
Sponsors
Pfizer
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to 28 days postdose (Up to 42 days) |
| Number of Participants Discontinuing Study Drug Due to an AE | Up to 14 days |
| Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin | Up to 17 days |
| Maximum plasma concentration (Cmax) of ertugliflozin | Up to 17 days |
| Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin | Up to 17 days |
| Ertugliflozin half life (t1/2) | Up to 17 Days |
| Apparent clearance (CL/F) after a single dose of ertugliflozin | Up to 17 days |
| Apparent volume of distribution (Vz/F) | Up to 17 days |
| Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs]) | Up to 17 days |
| Change from baseline in 24-hour weighted mean glucose | Baseline and Day 14 |
| 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 |
| Inhibition of glucose reabsorption | Baseline and Day 14 |
| Change from baseline in body weight | 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 |
| Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone | Up to 17 days |
| Trough concentration of serum intact parathyroid hormone (Ctrough) | Up to 17 days |
Outcome results
None listed