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A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers

NCT01051232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-04-26

No results posted yet for this study

Summary

A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.

Conditions

  • Healthy

Interventions

DRUG

Active

Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.

DRUG

Placebo

Two subjects will receive the placebo under fasting condition.

DRUG

Active

Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.

DRUG

Placebo

Two subjects will receive the placebo under fasting condition.

DRUG

Active

Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.

DRUG

Placebo

Two subjects will receive the placebo under fasting condition.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Japan

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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 NCT01051232 on ClinicalTrials.gov