Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889690
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2021-05-12
Brief Title:
Study of Multiple Doses of Danicopan in Healthy Participants
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Multiple Ascending Dose Study To Assess Safety Tolerability Pharmacokinetics And Pharmacodynamics Of ACH-0144471 In Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-05
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 was a multiple ascending dose randomized double-blind study assessing the safety tolerability pharmacokinetics and pharmacodynamics of danicopan in healthy participants Four different doses 75 milligrams mg 200 mg 500 mg 800 mg and dose-matched placebo were administered under fasted conditions
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None