Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03389321
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2017-12-27
Brief Title:
Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Single-center Open-label One-sequence Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension PAH and may be administered concomitantly The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics PK ie amount and time of presence in the blood of riociguat of a single dose of riociguat in healthy male subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-003502-41 | EUDRACT_NUMBER | None | None |