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Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects

NCT01159626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-04-20

No results posted yet for this study

Summary

This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-03463275 oral controlled release formulation in Japanese and Western male subjects.

Conditions

  • Healthy

Interventions

DRUG

PF-03463275

Oral single 20 mg dose as two 10mg controlled release tablets

DRUG

PF-03463275

Oral single 40 mg dose as four 10mg controlled release tablets

DRUG

PF-03463275

Oral single 60 mg dose as six 10mg controlled release tablets

DRUG

Placebo

Oral single dose as matching placebo

DRUG

PF-03463275

Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days

DRUG

Placebo

Oral multiple doses as matching placebo for 7 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
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

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 NCT01159626 on ClinicalTrials.gov