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

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ClinicalTrials.gov Identifier: NCT01051232
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : April 26, 2010
Sponsor:
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Active Drug: Placebo Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : February 2010
Primary Completion Date : April 2010
Study Completion Date : April 2010

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Safety; ECGs/vital signs [ Time Frame: Screening to Follow-up (Day 5) ]
  2. Safety; laboratory tests [ Time Frame: Screening to Follow-up (Day 5) ]
  3. Safety; physical examination/adverse event monitoring [ Time Frame: Screening to Follow-up (Day 5) ]

Secondary Outcome Measures :
  1. Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations [ Time Frame: Day 1 to Day 3 ]
  2. Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations [ Time Frame: Day 1 to Day 3 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051232


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01051232     History of Changes
Other Study ID Numbers: A8121035
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010

Keywords provided by Pfizer:
filibuvir
pharmacokinetics
Japanese
Asian