A Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07538973
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Anecatibin Fumarate Capsules — DRUG
    Anecatibin fumarate capsule is a prodrug that can be rapidly hydrolyzed into crizotinib in vivo to exert pharmacodynamic effects. Crizotinib is a tyrosine kinase receptor inhibitor, including Anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor Hepatocyte Growth Factor Receptor(HGFR, c-Met), ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1, c-cos), and Recepteur d'Origine Nantais (RON).

Study Details

Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function

Key Dates

First listed
Apr 20, 2026
Start date
Apr 30, 2026
Status verified
Sep 2025
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anecatibin Fumarate Capsules (TQ-B3101 Capsules)
    The dose is 300 mg, administered once.

Primary Outcome Measure

To determine the Cmax [ Time Frame: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days ]

Central Contacts

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