Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01928147
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2013-08-19
Brief Title:
A Phase 1a1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
Sponsor:
Presidio Pharmaceuticals Inc
Organization:
Presidio Pharmaceuticals Inc
Study Overview
Official Title:
A Phase Ia and Ib Dose-Ranging Study to Assess the Safety Pharmacokinetics and Antiviral Efficacy of PPI-383 in Healthy Adults and Hepatitis C Patients
Status:
COMPLETED
Status Verified Date:
2015-11
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:
PPI-383 is an antiviral agent an inhibitor of the hepatitis C virus NS5B polymerase that is being developed as a potential treatment for hepatitis C virus infection This study is being done to assess the dose-related safety and tolerance of PPI-383 when given to healthy volunteers for up to 5 days Part I of the study and to hepatitis C patients for up to 3 days Part II In addition the study will assess how much PPI-383 is absorbed into the bloodstream In Part II the dose-related effect of PPI-383 on the amount of hepatitis C virus in patients bloodstream serum HCV RNA levels also will be assessed
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