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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Active; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01051232

A8121035

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

24 participants in 3 patient groups, including a placebo group

Cohort 1

Placebo Comparator group

Description:

PF-00868554 (filibuvir) 100 mg or placebo

Treatment:

Drug: Placebo

Drug: Active

Drug: Active

Drug: Active

Drug: Placebo

Drug: Placebo

Cohort 2

Placebo Comparator group

Description:

PF-00868554 (filibuvir) 300 mg or placebo

Treatment:

Drug: Placebo

Drug: Active

Drug: Active

Drug: Active

Drug: Placebo

Drug: Placebo

Cohort 3

Placebo Comparator group

Description:

PF-00868554 (filibuvir) 500 mg or placebo

Treatment:

Drug: Placebo

Drug: Active

Drug: Active

Drug: Active

Drug: Placebo

Drug: Placebo