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

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

Official Title
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A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Active
* Drug: Placebo
* Drug: Active
* Drug: Placebo
* Drug: Active
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cohort 1<br>PF-00868554 (filibuvir) 100 mg or placebo | Drug: Active<br>* Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.<br>Drug: Placebo<br>* Two subjects will receive the placebo under fasting condition.<br>|
| Placebo Comparator: Cohort 2<br>PF-00868554 (filibuvir) 300 mg or placebo | Drug: Active<br>* Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.<br>Drug: Placebo<br>* Two subjects will receive the placebo under fasting condition.<br>|
| Placebo Comparator: Cohort 3<br>PF-00868554 (filibuvir) 500 mg or placebo | Drug: Active<br>* Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.<br>Drug: Placebo<br>* Two subjects will receive the placebo under fasting condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations |  | Day 1 to Day 3 | 
| Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations |  | Day 1 to Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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filibuvir, pharmacokinetics, Japanese, Asian