Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07844967 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506

Study acronym: HS-10506-114
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Moderate Hepatic Impairment Study Phase This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase: Cohort A: Subjects with moderate hepatic impairment Cohort B: Subjects with normal hepatic function A total of 8 subjects of either gender will be enrolled in each cohort. Enrolled subjects will be admitted to the Phase I clinical research unit on Day -1 and fasted for at least 10 hours. On Day 1, subjects will receive a single oral dose of 20 mg HS-10506 tablets in a fasted state. Water intake is prohibited within 1 hour before and after dosing (excluding water used for drug administration). Food intake is restricted for at least 4 hours post-dose. All study medications will be administered with approximately 240 mL of water. Subjects with normal hepatic function (Cohort B) serve as the matched control group for subjects with moderate hepatic impairment (Cohort A), and shall meet the following matching criteria: The mean body mass index (BMI) of Cohort B is within ±10% of the mean BMI of Cohort A. The mean age of Cohort B is within ±3 years of the mean age of Cohort A. The number of male and female subjects in Cohort B is consistent with that in Cohort A for each gender. Mild Hepatic Impairment Study Phase Based on the results of the moderate hepatic impairment study phase, the sponsor and principal investigator will jointly determine whether to conduct a study to evaluate the effect of mild hepatic impairment. The phase design and procedures of the mild hepatic impairment are consistent with those of the moderate hepatic impairment. Subjects with normal hepatic function (Cohort D) serve as the matched control group for subjects with mild hepatic impairment (Cohort C), and shall meet the following matching criteria: The mean BMI of Cohort D is within ±10% of the mean BMI of Cohort C. The mean age of Cohort D is within ±3 years of the mean age of Cohort C. The number of male and female subjects in Cohort D is consistent with that in Cohort C for each gender.
Trial Details
NCT Number NCT07844967
Lead Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov