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

NCT04552808 | Completed Phase 1

• 1 other identifier: PCD-DDAG181PA-18-004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Incidence of adverse events

  From Days 1-7

• Cmax

  Maximum plasma concentration of study drugs

  From Days 1-5

• AUC

  Maximum plasma concentration of study drugs

  From Days 1-5

Study Arms (1)

Yimitasvir Phosphate Capsules

EXPERIMENTAL

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

Drug: Yimitasvir Phosphate

Interventions

Yimitasvir Phosphate 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 Capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
• subjects and must be 18 to 70 years of age inclusive.
• Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
• The gender and age (±5 years) of subjects in cohort A and C were paired with subjects in cohort B and D, respectively.
• 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);
• Physical examination and vital signs without clinically significant abnormalities.
• 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).
• 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).
• 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.

You may not qualify if:

• Use of \>5 cigarettes per day during the past 3 months.
• Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
• History of alcohol abuse .
• Donation or loss of blood over 400 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.
• Hepatitis B surface antigen (HBsAg) was screened for positivity.
• Have taken any drug (including prescription and non-prescription drugs, herbal preparations) within 2 weeks prior to taking the experimental drug.
• ALT\>10×ULN；
• Absolute count of neutrophils \<0.75×10\^9/L;
• PLT\<50×10\^9/L
• HGB\<60 g/L
• 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.
• eGFR\<60 mL/min/1.73m\^2.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

yimitasvir

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is divided into four cohorts: healthy subjects in cohort A and C, moderate liver function impairment subjects in cohort B, and severe liver function impairment subjects in cohort D. Cohorts A and B, C and D should be matched in terms of gender, age, and body mass index (BMI).

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: October 19, 2020
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: October 27, 2022

Record last verified: 2020-10

Locations

CN (1)