NCT04798638

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

Studies to Compare the Pharmacokinetics of TY-9591 Tablets and Osimertinib Mesylate Tablets After a Single Fasting Administration and Determine the Effect of Food on the Pharmacokinetics of TY-9591 Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To assess the pharmacokinetics of TY-9591 tablets and Osimertinib Mesylate tablets after a single fasting administration and the effect of food on the pharmacokinetics of TY-9591 tablets in healthy volunteers.

Detailed description

This is a single center, randomized, open label, two phases study in healthy adult volunteers. The first phase is a two-sequence, two-period crossover trial. The volunteers will be randomly distributed into two groups and given either TY-9591 tablets or Osimertinib Mesylate tablets on a single fasting administration. In the second phase, all volunteers will be administrated TY-9591 tablets after a high fat meal. The washout between each treatment is no less than 21 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-30
• Primary completion: 2021-09-09
• Completion: 2021-09-09
• First posted: 2021-03-15
• Last updated: 2022-12-07

Locations

1 site across 1 country: China