Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 10:43 PM
Study NCT ID:
NCT01051232
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
Sponsor:
Pfizer
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: