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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Yimitasvir Phosphate Capsule

• Registration Number: NCT04565171
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-25
• Study Start: 2021-04-15
• Primary Completion: 2022-05-07
• Study Completion: 2022-05-07
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with renal impairment	Yimitasvir Phosphate Capsule	Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule.
Participants with normal renal function	Yimitasvir Phosphate Capsule	Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	From Days 1-5	The incidence of adverse events will be summarized

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China