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

NCT ID: NCT04565171

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2022-05-07

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants with renal impairment

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

Group Type: EXPERIMENTAL

Yimitasvir Phosphate Capsule

Intervention Type: DRUG

DAG181 100 mg (100 mg Capsule) administered orally

Participants with normal renal function

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

Group Type: EXPERIMENTAL

Yimitasvir Phosphate Capsule

Intervention Type: DRUG

DAG181 100 mg (100 mg Capsule) administered orally

Interventions

Yimitasvir Phosphate Capsule

DAG181 100 mg (100 mg Capsule) administered orally

Intervention Type: DRUG

Other Intervention Names

DAG181

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jia Miao, Doctor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

PCD-DDAG181PA-18-001

Identifier Type: -

Identifier Source: org_study_id