Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02882425
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2016-08-18
Brief Title:
Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Single-center Open-label Phase 1 Study Consisting of a Single-dose Pilot Phase and a Randomized Two-way Crossover Single-dose Main Phase to Investigate the Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2017-02
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:
The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag ie to assess the amount of selexipag which reaches the blood when administered as an oral tablet ACT-293987 compared to an intravenous administration in healthy subjects
Detailed Description:
A pilot phase was conducted in 3 male subjects before the main phase for assessment of absolute bio-availability conducted in 16 other male subjects The pilot phase aimed to determine the intravenous dose to be used in the main phase based on safety data and pharmacokinetics data
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