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

Official Title: “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”

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.

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

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Cohort 1
  • PF-00868554 (filibuvir) 100 mg or placebo
• Placebo Comparator: Cohort 2
  • PF-00868554 (filibuvir) 300 mg or placebo
• Placebo Comparator: Cohort 3
  • PF-00868554 (filibuvir) 500 mg or placebo

Primary Measures

• Safety; ECGs/vital signs
  • Time Frame: Screening to Follow-up (Day 5)
    Safety Issue?: Yes
• Safety; laboratory tests
  • Time Frame: Screening to Follow-up (Day 5)
    Safety Issue?: Yes
• Safety; physical examination/adverse event monitoring
  • Time Frame: Screening to Follow-up (Day 5)
    Safety Issue?: No

Secondary Measures

• Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations
  • Time Frame: Day 1 to Day 3
    Safety Issue?: Yes
• Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations
  • Time Frame: Day 1 to Day 3
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01051232

Study ID Number: A8121035

ClinicalTrials.gov Identifier: NCT01051232

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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