Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-03 @ 3:01 PM
Study NCT ID:
NCT02753218
Status:
TERMINATED
Last Update Posted:
2017-05-03
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study With LEO 32731 and Midazolam in Healthy Male Subjects
Sponsor:
LEO Pharma
Organization:
Study Overview
Official Title:
LEO 32731 - A Phase I Drug-Drug Interaction Study With LEO 32731 and Midazolam in Healthy Male Subjects
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to tolerability issues related to the dose titration, unexpected withdrawals were observed and it was unlikely for the trial to meet its objectives
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of multiple oral doses of LEO 32731 on the pharmacokinetics of a single oral dose of the cytochrome P450 3A substrate midazolam in healthy male subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: