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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: Yimitasvir Phosphate Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female, age 18 to 70 years of age, inclusive; must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening; 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); matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group; Exclusion Criteria: allergies constitution ( multiple drug and food allergies); Use of >5 cigarettes per day during the past 3 months; A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody； History of alcohol abuse； Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug； Subjects deemed unsuitable by the investigator for any other reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with renal impairment<br>Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule. | Drug: Yimitasvir Phosphate Capsule<br>* DAG181 100 mg (100 mg Capsule) administered orally<br>* Other names: DAG181;|
| Experimental: Participants with normal renal function<br>Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule. | Drug: Yimitasvir Phosphate Capsule<br>* DAG181 100 mg (100 mg Capsule) administered orally<br>* Other names: DAG181;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC | AUC is defined as the concentration of drug area under the curve | From Days 1-5 | 
| Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax | Cmax is defined as the maximum concentration of drug | From Days 1-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | The incidence of adverse events will be summarized | From Days 1-5 |