Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02944487
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2016-10-24
Brief Title:
A Study to Assess the Safety and Pharmacokinetics of Lucerastat OGT 923 in Healthy Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Ascending Dose Tolerance Study of OGT 923 in Healthy Male Volunteers
Status:
COMPLETED
Status Verified Date:
2016-10
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 objectives of this study were to evaluate the safety and tolerability of lucerastat and to determine its pharmacokinetic profile as single oral doses at different strengths
Detailed Description:
The subjects were enrolled sequentially to five dose groups starting with the lowest dose level Subjects could participate in only one Group
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