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

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Yimitasvir Phosphate Capsule
Sponsored by
Sunshine Lake Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants with renal impairment

Participants with normal renal function

Arm Description

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

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

Outcomes

Primary Outcome Measures

Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
AUC is defined as the concentration of drug area under the curve
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax
Cmax is defined as the maximum concentration of drug

Secondary Outcome Measures

Incidence of adverse events
The incidence of adverse events will be summarized

Full Information

First Posted
September 22, 2020
Last Updated
October 25, 2022
Sponsor
Sunshine Lake Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04565171
Brief Title
Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
May 7, 2022 (Actual)
Study Completion Date
May 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with renal impairment
Arm Type
Experimental
Arm Description
Participants with End-stage renal disease will receive a single dose of Yimitasvir Phosphate Capsule.
Arm Title
Participants with normal renal function
Arm Type
Experimental
Arm Description
Participants with normal renal function will receive a single dose of Yimitasvir Phosphate Capsule.
Intervention Type
Drug
Intervention Name(s)
Yimitasvir Phosphate Capsule
Other Intervention Name(s)
DAG181
Intervention Description
DAG181 100 mg (100 mg Capsule) administered orally
Primary Outcome Measure Information:
Title
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC
Description
AUC is defined as the concentration of drug area under the curve
Time Frame
From Days 1-5
Title
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax
Description
Cmax is defined as the maximum concentration of drug
Time Frame
From Days 1-5
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
The incidence of adverse events will be summarized
Time Frame
From Days 1-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jia Miao, Doctor
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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