Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02571855
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2015-10-02
Brief Title:
A Study to Investigate the Safety Tolerability Pharmacokinetics PK and Pharmacodynamics PD of ACT-541468 in Healthy Young Adults and Elderly Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Double-blind Placebo-controlled Randomized Study to Investigate the Tolerability Safety Pharmacokinetics and Pharmacodynamics of ACT-541468 Part A Multiple-ascending Doses in Healthy Young Adults After Morning Administration Part B Single-ascending Doses in Healthy Elderly Subjects After Morning Administration Part C Repeated Doses in Both Healthy Young Adults and Elderly Subjects After Evening Administration
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 purpose of this study is to evaluate the tolerability safety pharmacokinetics PK or amount of drug over time in the body and pharmacodynamics PD or effects on the body of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when administered in the morning The safety PK and PD of ACT-541468 will also be assessed after repeated evening administration of a selected dose in both healthy adults and elderly
Detailed Description:
In the first-in-man study single doses of ACT-541468 administered in healthy young adults were well tolerated up to the dose level of 200 mg inclusive and yielded results compatible with possible sleep facilitating effects of ACT-541468 So the present study aimed to further investigate the effects of ACT-541468 after multiple ascending doses in healthy young subjects as well as after single ascending doses in elderly subjects morning administrations The effects of repeated administrations of a selected dose administered in the evening in both healthy adults and elderly will also be investigated
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