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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: Yimitasvir Phosphate Capsule

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.
• Investigators: Principal Investigator: jia Miao, Doctor, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): May 7, 2022
• Study Completion (Actual): May 7, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Anti-Infective Agents; Antiviral Agents; Yimitasvir
• Other Study ID Numbers: PCD-DDAG181PA-18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No