Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Ertugliflozin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01223339

8835-041

Details and patient eligibility

About

This study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729, MK-8835) in Japanese healthy participants. The secondary objective is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin in Western healthy participants as compared to Japanese healthy participants.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and/or female subjects of non-childbearing potential, between the ages of 18 and 55 years, inclusive
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Japanese subjects must have four Japanese grandparents who were born in Japan.
Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
An informed consent document signed and dated by the subject.
Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
Asian or Polynesian subjects in Western subject groups.
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen.
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of screening.
History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent).
Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
12-lead ECG demonstrating QTc >450 msec at screening.
Subjects with ANY of the following abnormalities on safety laboratory tests):
Evidence of glycosuria, as defined by a positive urine dipstick test;
Fasting serum triglyceride >300 mg/dL;
Fasting LDL-cholesterol > than or equal to 190 mg/dL.
Fasting serum glucose >125 mg/dL.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 3 patient groups

Single Dose Japanese Cohort

Experimental group

Description:

This will be a single dose Cohort in which Japanese healthy participants will receive 3 ascending single doses (1 mg, 5 mg, and 25 mg) of ertugliflozin or placebo through 3 dosing periods. A minimum wash out period of 7-days will be set between each dose administration.

Treatment:

Drug: Ertugliflozin

Drug: Placebo

Single dose Western cohort

Experimental group

Description:

This will be a single dose Cohort in which Western healthy participants will receive 3 ascending single doses (1 mg, 5 mg, and 25 mg) of ertugliflozin through 3 dosing periods. A minimum wash out period of 7-days will be set between each dose administration.

Treatment:

Drug: Ertugliflozin

Multiple Dose Japanese Cohort

Experimental group

Description:

This will be a multiple dose Cohort in which Japanese healthy participants will receive once-daily 25 mg ertugliflozin or placebo for 7 days.

Treatment:

Drug: Ertugliflozin

Drug: Placebo