Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05806567
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2023-03-28
Brief Title:
A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects
Sponsor:
Kadmon a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Three-part Sequential Non-randomized Open-label Study Designed to Evaluate the Effect of Oral Belumosudil on UGT1A1 P-gp BCRP and OATP1B1 Inhibition in the Fed State in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2023-07
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 safety and pharmacokinetics PK effect of belumosudil on the uridine diphosphate glucuronosyltransferase UGT1A1 Part 1 P glycoprotein P-gp Part 2 and breast cancer resistance protein BCRPorganic anion transporting polypeptide OATP1B1 Part 3 inhibition in the fed state in healthy male subjects
Detailed Description:
Part 1 The estimated time from screening until the follow-up phone call is approximately 6 weeks per subject
Part 2 The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject
Part 3 The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects
Part 2 The estimated time from screening until the follow-up phone call is approximately 7 weeks per subject
Part 3 The estimated time from screening until the follow-up phone call is approximately 7 weeks per subjects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1277-6732 | REGISTRY | ICTRP | None |