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

January 14, 2010
April 22, 2010
February 2010
April 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01051232 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy
  • 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: Active
    Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
  • Placebo Comparator: Cohort 1
    PF-00868554 (filibuvir) 100 mg or placebo
    Interventions:
    • Drug: Active
    • Drug: Placebo
  • Placebo Comparator: Cohort 2
    PF-00868554 (filibuvir) 300 mg or placebo
    Interventions:
    • Drug: Active
    • Drug: Placebo
  • Placebo Comparator: Cohort 3
    PF-00868554 (filibuvir) 500 mg or placebo
    Interventions:
    • Drug: Active
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01051232
A8121035
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP