Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427544
Status:
COMPLETED
Last Update Posted:
2007-12-05
First Post:
2007-01-25
Brief Title:
Study of the Safety Tolerability and PK of PRA-027 Administered to Women of Nonchildbearing Potential
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
Ascending Single Dose Study of the Safety Tolerability Pharmacokinetics and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential The secondary purpose is to provide the initial pharmacokinetic PK and pharmacodynamic PD profile of PRA-027 in healthy women of nonchildbearing potential and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None