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

NCT04565171 | Completed Phase 1

• 1 other identifier: PCD-DDAG181PA-18-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of adverse events

  From Days 1-5

Study Arms (2)

Participants with renal impairment

EXPERIMENTAL

Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule.

Drug: Yimitasvir Phosphate Capsule

Participants with normal renal function

EXPERIMENTAL

Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule.

Drug: Yimitasvir Phosphate Capsule

Interventions

Yimitasvir Phosphate Capsule DRUG

DAG181 100 mg (100 mg Capsule) administered orally

Also known as: DAG181

Participants with normal renal function; Participants with renal impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

yimitasvir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• jia Miao, Doctor

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: April 15, 2021
• Primary Completion: May 7, 2022
• Study Completion: May 7, 2022
• Last Updated: October 27, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)