Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03017495
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2017-01-10
Brief Title:
A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Single-center Open-label Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 and the Effect of Single- and Multiple-dose ACT-541468 on the Pharmacokinetics of Midazolam and Its Metabolite 1-Hydroxymidazolam 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 objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics ie how long and how much a compound is present in the blood of ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam a CYP3A4 substrate
Detailed Description:
Food effect will be assessed by comparing the pharmacokinetic PK parameters of a single dose of ACT-541468 under fasted Treatment B and fed Treatment C conditions
Potential CYP3A4 inhibiting inducing effects of ACT-541468 will be assessed by comparing the PK parameters of midazolam alone Treatment A and midazolam given with a single dose of ACT-541468 Treatment B or with multiple doses of ACT-541468 Treatment D
Potential CYP3A4 inhibiting inducing effects of ACT-541468 will be assessed by comparing the PK parameters of midazolam alone Treatment A and midazolam given with a single dose of ACT-541468 Treatment B or with multiple doses of ACT-541468 Treatment D
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 |
|---|---|---|---|
| 2016-003490-18 | EUDRACT_NUMBER | None | None |