Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326723
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-02-17
Brief Title:
Investigate the PK Safety and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
Sponsor:
Jiangsu Simcere Pharmaceutical Co Ltd
Organization:
Jiangsu Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
A Single-Center Randomized Double-Blind Placebo-Controlled Phase 1 Clinical Study to Investigate the Pharmacokinetics Safety and Tolerability After Single- and Multiple-Dose Daridorexant in Chinese Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-02
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:
This clinical study is a single-center randomized double-blind placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects
Detailed Description:
This clinical study is a single-center randomized double-blind placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in healthy adult Chinese subjects This study will consist of a 20-day screening period a 1-day baseline a 11-day in patient period and a 27-day follow-up period The subjects will arrive at the study site on Day -1 and the subjects will be discharged from the study site on Day11
32 healthy subjects 18-55 years will be randomized Two dose levels are planned 25 mg and 50 mg 16 healthy subjects will be randomized with a ratio of 31 to receive 25mg daridorexant or matched placebo and another 16 healthy subjects will be randomized with a ratio of 31 to receive 50mg daridorexant or matched placebo On Day 1 each subject will receive a single dose of daridorexant or placebo in the morning under fast conditions and PK samples will be collected up to 72 h post dose Subject will receive repeated doses of daridorexant or placebo from day 4 to day 8 QD in the morning under fasting conditions and PK samples will be collected up to 72 h post last dose The final follow-up visit will be conducted on Day 38 30 days after the last dose
32 healthy subjects 18-55 years will be randomized Two dose levels are planned 25 mg and 50 mg 16 healthy subjects will be randomized with a ratio of 31 to receive 25mg daridorexant or matched placebo and another 16 healthy subjects will be randomized with a ratio of 31 to receive 50mg daridorexant or matched placebo On Day 1 each subject will receive a single dose of daridorexant or placebo in the morning under fast conditions and PK samples will be collected up to 72 h post dose Subject will receive repeated doses of daridorexant or placebo from day 4 to day 8 QD in the morning under fasting conditions and PK samples will be collected up to 72 h post last dose The final follow-up visit will be conducted on Day 38 30 days after the last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None