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

NCT ID: NCT04552808

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2022-06-09

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yimitasvir Phosphate Capsules

The mechanism of action of Yimitasvir is the specific inhibition of HCV non-structural protein NS5A

Group Type: EXPERIMENTAL

Yimitasvir Phosphate

Intervention Type: DRUG

Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects

Yimitasvir Phosphate

Intervention Type: DRUG

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.

Yimitasvir Phosphate

Intervention Type: DRUG

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.

Yimitasvir Phosphate

Intervention Type: DRUG

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.

Interventions

Yimitasvir Phosphate

Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.

2. subjects and must be 18 to 70 years of age inclusive.

3. Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.

1. The gender and age (±5 years) of subjects in cohort A and C were paired with subjects in cohort B and D, respectively.

2. Body mass index (BMI) : 18-30 kg/m^2 (including critical value) [BMI= weight (kg)/height^2 (m^2)] (BMI matching ±15% with liver dysfunction cohort);

3. Physical examination and vital signs without clinically significant abnormalities.

1. Body mass index (BMI) between 18 and 28 kg/m^2 (including critical value) is allowed for subjects with liver insufficiency without ascites or subjects with subclinical ascites detected only by ultrasound or other imaging.Subjects with clinically significant ascites with liver dysfunction were allowed to have a BMI of 18~30 kg/m^2 (including a threshold).

2. During screening, the severity of patients with liver dysfunction was evaluated according to the Child-Pugh classification : (B/moderate: Child-Pugh score 7~9; Grade C/Severe: Child Pugh score 10~15 points).

3. The liver function status of the subjects was determined to be stable between 1 month before taking the experimental drug and the end of the study, with no significant change.

Exclusion Criteria

1. Use of >5 cigarettes per day during the past 3 months.

2. Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).

3. History of alcohol abuse .

4. Donation or loss of blood over 400 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.

1. Hepatitis B surface antigen (HBsAg) was screened for positivity.

2. Have taken any drug (including prescription and non-prescription drugs, herbal preparations) within 2 weeks prior to taking the experimental drug.

1. ALT>10×ULN；

2. Absolute count of neutrophils <0.75×10^9/L;

3. PLT<50×10^9/L

4. HGB<60 g/L

5. AFP >100 ng/mL; If 20 ng/mL≤AFP≤100 ng/mL, liver ultrasound examination or other imaging examinations (CT, MRI, etc.) are required to exclude subjects with suspected HCC.

6. eGFR<60 mL/min/1.73m^2.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

PCD-DDAG181PA-18-004

Identifier Type: -

Identifier Source: org_study_id