Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT06089733
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2023-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Effect of Itraconazole and Rifampicin on ABSK021
Sponsor:
Abbisko Therapeutics Co, Ltd
Organization:
Study Overview
Official Title:
a Single-center, Open-label, Fixed Sequence Study in Healthy Chinese Subjects to Evaluate the Pharmacokinetic Effects of Itraconazole and Rifampicin on Oral Administration of a Single Dose of ABSK021
Status:
COMPLETED
Status Verified Date:
2023-06
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:
This study is a single center, open lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of ABSK021 Oral administration. It is planned to enroll 32 healthy subjects and assign them to two parallel test groups, Part A (ABSK021 combined with Itraconazole) and Part B (ABSK021 combined with Rifampicin).
Detailed Description:
Each study section includes a screening period conducted within 28 days prior to the first administration of the investigational drug, a trial period of 2 cycles, and withdrawal visits on the 21st or 14th day (Part A) or 14th day (Part B) after the last dose of ABSK021. This study will end after all participants complete 2 cycles of the trial period and withdraw from the study visit.
Whether subjects who have completed the first cycle of the study will enter the second cycle of the study will be determined by the researcher based on their physical condition and relevant visit examination results. For the subjects who interrupted or permanently suspended the study due to adverse events or clinically significant laboratory Outlier, the interview rate shall be determined according to the requirements of the research institution or the clinical indication syndrome until the AE is resolved or stabilized, whichever occurs first.
Whether subjects who have completed the first cycle of the study will enter the second cycle of the study will be determined by the researcher based on their physical condition and relevant visit examination results. For the subjects who interrupted or permanently suspended the study due to adverse events or clinically significant laboratory Outlier, the interview rate shall be determined according to the requirements of the research institution or the clinical indication syndrome until the AE is resolved or stabilized, whichever occurs first.
Study Oversight
Has Oversight DMC:
False
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?: