Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD

• Status: Recruiting
• Trial end date: 2022-10-27
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Yimitasvir

Criteria

Inclusion Criteria:

1. male or female, age 18 to 70 years of age, inclusive;

2. must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening;

3. Glomerular filtration rate must be < 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min for Normal Renal Function group(using MDRD method);

4. matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group;

Exclusion Criteria:

1. allergies constitution ( multiple drug and food allergies);

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

3. A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody；

4. History of alcohol abuse；

5. Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug；

6. Subjects deemed unsuitable by the investigator for any other reason.