To Evaluate the Pharmacokinetics and Safety of TQ05105 Tablet in Hepatic Impairment Subjects

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07480824
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • TQ05105 — DRUG
    Janus Kinase Inhibitors/Rho-associated Kinase (JAK/ROCK) inhibitors

Study Details

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.

Key Dates

First listed
Mar 18, 2026
Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A: Mild hepatic impairment (Child-Pugh A)
    A: 15 mg orally , single dose
  • Active Comparator: B: Moderate hepatic impairment (Child-Pugh B)
    B: 10 mg orally , single dose
  • Active Comparator: C: Normal
    C: 15 mg orally , single dose

Primary Outcome Measure

Peak concentration (Cmax) [ Time Frame: Before administration, 10, 20, 30, 45 minuets，1, 2, 3, 4, 6, 8, 12, 24, 48 hours after administration ]

Central Contacts

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