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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565171
• Other study ID #: PCD-DDAG181PA-18-001
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2021
• Est. completion date: May 7, 2022

Study information

• Verified date: September 2020
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 7, 2022
• Est. primary completion date: May 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Yimitasvir Phosphate Capsule
DAG181 100 mg (100 mg Capsule) administered orally

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax	Cmax is defined as the maximum concentration of drug	From Days 1-5
Secondary	Incidence of adverse events	The incidence of adverse events will be summarized	From Days 1-5