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NCT01051232 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01051232
Other study ID # A8121035
Secondary ID
Status Completed
Phase Phase 1
First received January 14, 2010
Last updated April 22, 2010
Start date February 2010
Est. completion date April 2010

Study information
Verified date April 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
• Placebo
Two subjects will receive the placebo under fasting condition.
• Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
• Placebo
Two subjects will receive the placebo under fasting condition.
• Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
• Placebo
Two subjects will receive the placebo under fasting condition.

Locations
Country Name City State
Japan Pfizer Investigational Site Shinjuku-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety; ECGs/vital signs Screening to Follow-up (Day 5) Yes
Primary Safety; laboratory tests Screening to Follow-up (Day 5) Yes
Primary Safety; physical examination/adverse event monitoring Screening to Follow-up (Day 5) No
Secondary Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations Day 1 to Day 3 Yes
Secondary Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations Day 1 to Day 3 Yes
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