Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT00856258
Status:
TERMINATED
Last Update Posted:
2009-12-23
First Post:
2009-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.
Detailed Description:
The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.
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?: