Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

StatusWithdrawn
PhasePhase 1
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: Study was withdrawn per sponsor decision after recruitment opened with no participants enrolled.
    • Enrollment target: estimated 32 to confirmed 0
    • Eligibility criteria expanded, about 32 words
    • Site contact updated
  2. Re-verified, no change to tracked fieldsv6
  3. Primary and study completion dates: Dec 30, 2024 to Dec 30, 2026
    • Start date: Dec 30, 2023 to Oct 30, 2026
    v5
  4. Primary and study completion dates: Nov 30, 2023 to Dec 30, 2024
    • Start date: Nov 8, 2022 to Dec 30, 2023
    v4
  5. Re-verified, no change to tracked fieldsv3
  6. Start date: Nov 8, 2021 to Nov 8, 2022v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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
Trial Details
NCT Number NCT05048368
Lead Sponsor Sunshine Lake Pharma Co., Ltd.
Conditions
(from sponsor)		 Esophageal Cancer, Advanced Solid Tumor
Related terms Esophageal Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov