Ignite Creation Date:
2024-05-06 @ 7:23 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02526888
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2015-08-14
Brief Title:
Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Single-center Open-label Randomized Two-way Crossover Study to Investigate the Effect of Multiple-dose Diltiazem on the Pharmacokinetics of a Single Dose of 25 mg ACT-541468 in Healthy Male Subjects
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 main objective of this study is to investigate whether repeated administration of a cardiac medication diltiazem can affect the pharmacokinetics ie amount and time of presence in the blood of ACT-541468
Detailed Description:
Because ACT-541468 appears to be mainly metabolized by CYP3A4 it is deemed of interest to investigate the potential influence of diltiazem a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468
Safety of the concomitant administration of the two drugs will also be assessed
Safety of the concomitant administration of the two drugs will also be assessed
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