Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05633147
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2022-11-21
Brief Title:
Effect of Clarithromycin on PK of Linaprazan Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
Sponsor:
Cinclus Pharma Holding AB
Organization:
Cinclus Pharma Holding AB
Study Overview
Official Title:
Effect of Repeated Dosing of Clarithromycin on PK of Linaprazan GlurateLinaprazan Effect of Single Dose of Linaprazan Glurate on PK of Clarithromycin SingleRepeated Dosing of Linaprazan Glurate on PK of Midazolam to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-08
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 is a phase I open-label fixed design drug-drug-interaction DDI study divided in 2 parts Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin a strong inhibitor of cytochrome P450 3A4 CYP3A4 and P-glycoprotein P PgP leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of linaprazan glurate Part II is designed to evaluate the effect of repeated doses of linaprazan glurate on the pharmacokinetics PK of a sensitive substrate of CYP3A midazolam
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?:
None
Is an FDA AA801 Violation?:
None