Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05643872
Status:
RECRUITING
Last Update Posted:
2022-12-09
First Post:
2022-11-08
Brief Title:
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 39 Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Sponsor:
Palvella Therapeutics Inc
Organization:
Palvella Therapeutics Inc
Study Overview
Official Title:
A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 39 Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita
Status:
RECRUITING
Status Verified Date:
2022-12
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:
PALV-08 is a multicenter open-label treatment OLT study enrolling adults with Pachyonychia Congenita PC with genotyped keratin mutations KRT6A KRT6B KRT6C or KRT16 who were previously enrolled in the PALV-05 VAPAUS trial
The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics PK of QTORIN rapamycin 39 anhydrous gel or PTX-022
The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics PK of QTORIN rapamycin 39 anhydrous gel or PTX-022
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None