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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01051232
First received: January 14, 2010
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Active
Drug: Placebo
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety; ECGs/vital signs [ Time Frame: Screening to Follow-up (Day 5) ] [ Designated as safety issue: Yes ]
  • Safety; laboratory tests [ Time Frame: Screening to Follow-up (Day 5) ] [ Designated as safety issue: Yes ]
  • Safety; physical examination/adverse event monitoring [ Time Frame: Screening to Follow-up (Day 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations [ Time Frame: Day 1 to Day 3 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cohort 1
PF-00868554 (filibuvir) 100 mg or placebo
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.
Placebo Comparator: Cohort 2
PF-00868554 (filibuvir) 300 mg or placebo
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.
Placebo Comparator: Cohort 3
PF-00868554 (filibuvir) 500 mg or placebo
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051232

Locations
Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01051232     History of Changes
Other Study ID Numbers: A8121035
Study First Received: January 14, 2010
Last Updated: April 22, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
filibuvir
pharmacokinetics
Japanese
Asian

ClinicalTrials.gov processed this record on April 17, 2014