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Completed

NCT Number: NCT04565171

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yimitasvir Phosphate Capsule

Drug

DAG181 100 mg (100 mg Capsule) administered orally

Other names: DAG181

Primary outcomes

  1. Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC

    Time frame: From Days 1-5

    AUC is defined as the concentration of drug area under the curve

  2. Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax

    Time frame: From Days 1-5

    Cmax is defined as the maximum concentration of drug

Secondary outcomes

  1. Incidence of adverse events

    Time frame: From Days 1-5

    The incidence of adverse events will be summarized

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2020
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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