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

NCT04798638 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-12-07

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • TYK Medicines, Inc

    lead INDUSTRY

Principal Investigators

  • Xue Chen, MD · Hunan Provincial Tumor Hospital

  • Kunyan Li, Ph.D · Hunan Provincial Tumor Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-09-09
Completion
2021-09-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798638 on ClinicalTrials.gov