NCT04798638View on ClinicalTrials.gov

A Study to Assess the Effect of Food on the Pharmacokinetics of TY-9591 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

April 30, 2021

Primary Completion Date

September 9, 2021

Study Completion Date

September 9, 2021

Conditions
Healthy Volunteers
Interventions
DRUG

TY-9591 Tablets under Fasted Condition - Arm1

Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.

DRUG

Osimertinib Mesylate Tablets under Fasted Condition - Arm1

Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.

DRUG

TY-9591 Tablets after a High-fat Meal - Arm1

Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.

DRUG

Osimertinib Mesylate Tablets under Fasted Condition - Arm2

Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.

DRUG

TY-9591 Tablets under Fasted Condition - Arm2

Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.

DRUG

TY-9591 Tablets after a High-fat Meal - Arm2

Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.

Trial Locations (1)

410006

Hunan Provincial Tumor Hospital, Changsha

All Listed Sponsors
lead

TYK Medicines, Inc

INDUSTRY