NCT04552808

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and Healthy Subjects in a Single-center, Non-randomized, Open, Single-dose Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration

Detailed description

A phase I, a single-center, non-randomized, open, single-dose administration study to explore the safety, pharmacokinetics of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects This study is divided into four cohorts, cohort A and cohort C in healthy subjects, cohort B for moderate liver function impairment participants, cohort D for severe liver function impairment, participants in cohort A and cohort B, group C and group D should be matched in terms of sex, age, and body mass index (BMI). A total of 32 subjects, 8 in each cohort, both male and female, are planned to be enrolled. If a complete PK blood sample is not collected due to subjects' early withdrawal from the study, new subjects will be enrolled to meet the pharmacokinetic parameters that can be evaluated for each cohort of 8 subjects.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Yimitasvir Phosphate	Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects
DRUG	Yimitasvir Phosphate	Cohort B: were subjects with moderate liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.
DRUG	Yimitasvir Phosphate	Cohort C: Cohort C are healthy subjects, cohorts C and D, should be matched in terms of sex, age, and body mass index (BMI). On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.
DRUG	Yimitasvir Phosphate	Cohort D: were subjects with severe liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.

Timeline

• Start date: 2020-10-19
• Primary completion: 2022-06-09
• Completion: 2022-06-09
• First posted: 2020-09-17
• Last updated: 2022-10-27

Locations

1 site across 1 country: China