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

Merck Sharp & Dohme LLC40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

ErtugliflozinDRUG

Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast

Placebo to ErtugliflozinDRUG

Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast

Eligibility

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

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants Experiencing an Adverse Event (AE)

Time frame: Up to 28 days postdose (Up to 42 days)

Number of Participants Discontinuing Study Drug Due to an AE

Time frame: Up to 14 days

Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin

Time frame: Up to 17 days

Maximum plasma concentration (Cmax) of ertugliflozin

Time frame: Up to 17 days

Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin

Time frame: Up to 17 days

Ertugliflozin half life (t1/2)

Time frame: Up to 17 Days

Apparent clearance (CL/F) after a single dose of ertugliflozin

Time frame: Up to 17 days

Apparent volume of distribution (Vz/F)

Time frame: Up to 17 days

Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs])

Time frame: Up to 17 days

Change from baseline in 24-hour weighted mean glucose

Time frame: Baseline and Day 14

Change from baseline in 24-hour urinary glucose excretion

Time frame: Baseline and Day 14

Change from baseline in 24-hour plasma C-peptide

Data from ClinicalTrials.gov

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