Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02919319
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2016-09-28
Brief Title:
A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Double-blind Placebo-controlled Randomized Single Ascending Dose Study to Investigate the Tolerability Safety Pharmacokinetics Pharmacodynamics Absolute Bioavailability Mass Balance and Metabolism of ACT-541468 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 first-into-man study were to investigate the safety tolerability and the pharmacokinetic profile of single oral doses of ACT-541468 in healthy male adults Pharmacodynamic effects through a battery of Central Nervous System tests were also assessed
Detailed Description:
The study consisted of ascending dose groups each dose group was investigated in a new group of 8 healthy male subjects 6 on active drug and 2 on placebo In addition the study included a biocomparison part dose group 2 an absolute bioavailability part dose group 4 and a mass balance metabolism part dose group 3
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 |
|---|---|---|---|
| 2014-003129-16 | EUDRACT_NUMBER | None | None |