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PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions

NCT01362673 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-10-07

No results posted yet for this study

Summary

This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.

Conditions

  • Healthy

Interventions

DRUG

PF-04171327

Oral single 5 mg dose as one 5 mg tablet

DRUG

PF-04171327

Oral single 10 mg dose as one 10 mg tablet

DRUG

PF-04171327

Oral single 30 mg dose as three 10 mg tablets

DRUG

Placebo

Oral single dose as matching placebo

DRUG

PF-04171327

Oral multiple 20 mg doses as two 10 mg tablets for 12 days

DRUG

Placebo

Oral multiple doses as matching placebo for 12 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01362673 on ClinicalTrials.gov