Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02770222
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2016-05-11
Brief Title:
A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Single-center Open-label Randomized Two-part Two-treatment Two-period Crossover Study to Investigate the Effect of Gemfibrozil or Rifampicin on the Pharmacokinetics of Selexipag and Its Metabolite ACT-333679 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2016-07
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 primary objectives of this 2-part drug interaction study are as follows
To evaluate the effect of gemfibrozil on the pharmacokinetics ie amount in the blood of selexipag and its metabolite ACT-333679 Part I
To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its metabolite ACT-333679 Part II
To evaluate the effect of gemfibrozil on the pharmacokinetics ie amount in the blood of selexipag and its metabolite ACT-333679 Part I
To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its metabolite ACT-333679 Part II
Detailed Description:
Because non-clinical studies have shown that selexipag and its active metabolite ACT-333679 are substrates for cytochrome P450 2C8 CYP2C8 the present clinical study aims at investigating the effect of a strong inhibitor gemfibrozil and a moderate inducer rifampicin of CYP2C8 on the pharmacokinetic of selexipag and ACT-333679 as recommended by the FDAs Guidance for Industry Drug Interaction Studies FDA 2012
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-000811-34 | EUDRACT_NUMBER | None | None |