Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02930655
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2016-10-10
Brief Title:
A Study to Assess the Safety and Tolerability of Lucerastat in Subjects With Fabry Disease
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Single-center Open-label Randomized Versus a Control Group Phase 1b Study to Evaluate the Safety Tolerability Pharmacodynamics and Pharmacokinetics of Oral Lucerastat in Adult Subjects With Fabry Disease Receiving Enzyme Replacement Therapy
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The primary purpose of this study was to assess the safety and tolerability of lucerastat in adults with Fabry Disease receiving Enzyme Replacement Therapy ERT
The secondary objectives were to investigate the effects of lucerastat on plasma and urine levels of biomarkers to assess its effects on renal and cardiac functions and to determine the pharmacokinetic profile of lucerastat at steady-state
The secondary objectives were to investigate the effects of lucerastat on plasma and urine levels of biomarkers to assess its effects on renal and cardiac functions and to determine the pharmacokinetic profile of lucerastat at steady-state
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