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

Merck Sharp & Dohme LLC24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

ErtugliflozinDRUG

Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.

Placebo to ErtugliflozinDRUG

Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of Participants Experiencing an Adverse Event (AE)

Time frame: Up to Day 10 of each dosing period

Number of Participants Discontinuing Study Drug Due to an AE

Time frame: Up to Day 8 of each dosing period

Change from baseline in 24-hour urinary glucose excretion

Time frame: Baseline and 24 hours

Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin