NCT04601766 - A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 30, 2020

Primary Completion Date

December 18, 2020

Study Completion Date

February 1, 2021

Conditions

Bladder Cancer

Interventions

DRUG

APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2

Phase1: Period 1 drug administration( APL-1202 50 mg, 3 tablets, orally );Washout( 7± 1 day) ; Period 2 drug administration(1501 ER Tablets 3 382 mg ASN-1324, 1 tablet); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)

DRUG

APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2

Phase1: Period 1 drug administration( 1501 ER Tablets 3 382 mg ASN-1324, 1 tablet );Washout( 7± 1 day) ; Period 2 drug administration(APL-1202 50 mg, 3 tablets, orally); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)

Trial Locations (1)

2031

Scientia clinical research, Randwick