Ignite Creation Date:
2024-05-06 @ 7:07 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02479204
Status:
TERMINATED
Last Update Posted:
2018-07-10
First Post:
2015-06-17
Brief Title:
Clinical Study to Investigate Safety and Effects on Heart Rate Blood Pressure and Pharmacokinetic Interactions of ACT-334441
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Single-center Open-label Randomized Multiple-dose Parallel-group Study to Investigate Safety and Effects on Heart Rate Blood Pressure and Pharmacokinetic Interactions of ACT-334441 Combined With Calcium-channel Blocker Diltiazem or Beta-blocker Atenolol Treatment in Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on results from the pilot phase the study is terminated No safety events leading to discontinuation were reported
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs
Detailed Description:
The study will consist of two parts a pilot part Part A that will be completed prior to the start of the main part Part B The Subjects who will participate in Part A are excluded from Part B
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