Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537715
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2020-07-29
Brief Title:
Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
Sponsor:
Epizyme Inc
Organization:
Ipsen
Study Overview
Official Title:
A Phase I Open-label Multi-dose Two-part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor and a Strong CYP3A4 Inducer on the Steady-State Pharmacokinetics of Tazemetostat EPZ-6438 in Subjects With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2024-04
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 participants of this study will have advanced malignancies also known as advanced cancer The main aim of this trial will be to study the blood levels known as pharmacokinetics of the tazemtostat the study drug when administered in combination with another drug
Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole
Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin
For both Parts 1 and 2 safety and the level that effects of the study drug can be tolerated known as tolerability will be assessed throughout
Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole
Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin
For both Parts 1 and 2 safety and the level that effects of the study drug can be tolerated known as tolerability will be assessed throughout
Detailed Description:
This two-part study is designed to characterize the steady-state PK of oral tazemetostat and its metabolite EPZ 6930 when administered as a single and twice daily dose in subjects with advanced malignancies while taken alone or in combination with either itraconazole or rifampin
Part 1 tazemetostat and Itraconazole Drug Interaction Part 1 of the study will evaluate the drug-drug interaction between tazemetostat and itraconazole in an open-label fixed sequential cross over design
Part 2 tazemetostat and Rifampin Drug Interaction Part 2 of the study will evaluate the drug-drug interaction between tazemetostat and rifampin in an open-label fixed sequential cross over design
For both Parts 1 and 2 safety and tolerability will be assessed throughout the subjects participation Subjects must have an end of study visit after 30 days of the last dose of tazemetostat for safety assessment
Part 1 tazemetostat and Itraconazole Drug Interaction Part 1 of the study will evaluate the drug-drug interaction between tazemetostat and itraconazole in an open-label fixed sequential cross over design
Part 2 tazemetostat and Rifampin Drug Interaction Part 2 of the study will evaluate the drug-drug interaction between tazemetostat and rifampin in an open-label fixed sequential cross over design
For both Parts 1 and 2 safety and tolerability will be assessed throughout the subjects participation Subjects must have an end of study visit after 30 days of the last dose of tazemetostat for safety assessment
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