Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954589
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2013-09-27
Brief Title:
Single-ascending Dose Study to Investigate the Tolerability Safety Pharmacokinetics and Pharmacodynamics of ACT-462206
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Double-blind Placebo- and Active-controlled Randomized Single-ascending Dose Study to Investigate the Tolerability Safety Pharmacokinetics and Pharmacodynamics of ACT-462206 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:
A study of ACT-462206 to evaluate the tolerability safety pharmacokinetics and pharmacodynamic of ascending single doses of ACT-462206 a novel dual orexin receptor antagonist in healthy male subjects
Detailed Description:
Each dose level will be investigated in a new group of eight healthy male subjects six on active drug and two on placebo Each subject will participate in one treatment period with the exception of subjects in the crossover part ie almorexant reference group at the fourth dose level who will participate in two treatment periods At this dose level subjects on active drug six will receive in one treatment period ACT-462206 and in the other 400 mg of almorexant subjects on placebo two will receive the corresponding placebos double-dummy
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