Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04459585
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2020-07-02
Brief Title:
A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
Sponsor:
Daiichi Sankyo Co Ltd
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 Open-Label Fixed Sequence Drug Interaction Study to Evaluate the Potential Intestinal Inhibitory Effect of Quizartinib on the Pharmacokinetics of a Pgp Substrate Dabigatran Etexilate in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-06
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 investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants
Detailed Description:
This study will evaluate the potential intestinal inhibitory effect of quizartinib on the pharmacokinetics of a Pgp substrate dabigatran etexilate in healthy participants
The hypothesis for this clinical study is that quizartinib as a P-gp inhibitor may increase the systemic exposure measured by area under the concentration-time curve AUC and maximum concentration Cmax of P-gp substrates that may be sensitive to intestinal P-gp inhibition
The hypothesis for this clinical study is that quizartinib as a P-gp inhibitor may increase the systemic exposure measured by area under the concentration-time curve AUC and maximum concentration Cmax of P-gp substrates that may be sensitive to intestinal P-gp inhibition
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