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

Sponsor
TYK Medicines, Inc
Study ID
NCT04798638
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • TY-9591 Tablets under Fasted Condition - Arm1 — DRUG
    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.
  • Osimertinib Mesylate Tablets under Fasted Condition - Arm1 — DRUG
    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.
  • TY-9591 Tablets after a High-fat Meal - Arm1 — DRUG
    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.
  • Osimertinib Mesylate Tablets under Fasted Condition - Arm2 — DRUG
    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.
  • TY-9591 Tablets under Fasted Condition - Arm2 — DRUG
    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.
  • TY-9591 Tablets after a High-fat Meal - Arm2 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2021
Status verified
Aug 2021
Primary completion
Sep 9, 2021
Completion
Sep 9, 2021

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm1: TY-9591 + Osimertinib + TY-9591
    Participants will receive TY-9591 tablets under fasted condition in period 1 , followed by Osimeritinib Mesylate tablet under fasted condition in period 2. In period 3, participants will receive TY-9591 tablet in fed state (high-fat meal). The washout will be no less than 21 days between each treatment.
  • Experimental: Arm2: Osimertinib + TY-9591 + TY-9591
    Participants will receive Osimeritinib Mesylate tablet under fasted condition in period 1 , followed by TY-9591 tablets under fasted condition in period 2. In period 3, participants will receive TY-9591 tablet in fed state (high-fat meal). The washout will be no less than 21 days between each treatment.

Primary Outcome Measure

Cmax of TY-9591 and its metabolites [ Time Frame: Blood samples are collected at pre-dose (within 1 hour) and 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 hours post-dose. ]

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