Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207682
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2024-01-05
Brief Title:
Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics PK of a Single Dose of Simvastatin
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-Label Phase 1 Study to Evaluate the Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics of a Single Dose of Simvastatin in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-12
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 primary objective of this clinical study is to evaluate the effect of repeated oral doses of avacopan 30 mg and 60 mg twice daily approximately 12 hours apart BID given under fed conditions on the PK of a single dose of simvastatin 40 mg in healthy volunteers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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