A Single-center, Non-randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and End-stage Renal Disease Without Hemodialysis

PCD-DDAG181PA-18-001

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.

2021-04-15

2022-05-07

2022-05-07

Completed

Early phase I

16

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

2022-10-27