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

NCT01223339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Ertugliflozin

Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state

DRUG

Placebo

Placebo tablets to Ertugliflozin administered in the fasted state

DRUG

Ertugliflozin

Ertugliflozin 25 mg tablets administered once daily in the fed state for 7 days

DRUG

Placebo

Placebo tablets administered once daily in the fed state for 7 days

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-02-28
Completion
2011-02-28

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01223339 on ClinicalTrials.gov