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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Active; Drug: Placebo

• Registration Number: NCT01051232
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.

Study Timeline

• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-18
• Study Start: 2010-02
• Status Verified: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male and female subjects between the ages of 20 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

Exclusion Criteria

• A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
• Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
• Pregnant or nursing females; females of childbearing potential.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Active	PF-00868554 (filibuvir) 100 mg or placebo
Cohort 1	Placebo	PF-00868554 (filibuvir) 100 mg or placebo
Cohort 2	Active	PF-00868554 (filibuvir) 300 mg or placebo
Cohort 2	Placebo	PF-00868554 (filibuvir) 300 mg or placebo
Cohort 3	Active	PF-00868554 (filibuvir) 500 mg or placebo
Cohort 3	Placebo	PF-00868554 (filibuvir) 500 mg or placebo

Primary Outcome Measures

Name	Time	Method
Safety; ECGs/vital signs	Screening to Follow-up (Day 5)
Safety; laboratory tests	Screening to Follow-up (Day 5)
Safety; physical examination/adverse event monitoring	Screening to Follow-up (Day 5)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations	Day 1 to Day 3
Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations	Day 1 to Day 3

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan