Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

Sponsor
Sunshine Lake Pharma Co., Ltd.
Study ID
NCT05048368
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Larotinib — DRUG
    Capsules, Oral, 350 mg, single dose, one day

Study Details

To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration

Key Dates

Start date
Oct 30, 2026
Status verified
May 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: Cohort A-Larotinib
    Cohort A:Healthy participants with normal hepatic function （match to subjects with mild hepatic impairment\_cohort B）
  • Experimental: Cohort B-Larotinib
    Subjects with mild hepatic impairment
  • Experimental: Cohort C-Larotinib
    Healthy participants with normal hepatic function （match to subjects with moderate hepatic impairment\_cohort D）
  • Experimental: Cohort D-Larotinib
    Subjects with moderate hepatic impairment.

Primary Outcome Measure

Cmax [ Time Frame: Day 1 to Day 7 ]

Central Contacts

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