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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Yimitasvir Phosphate Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT04565171

PCD-DDAG181PA-18-001

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Participants with renal impairment

Experimental group

Description:

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

Treatment:

Drug: Yimitasvir Phosphate Capsule

Participants with normal renal function

Experimental group

Description:

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

Treatment:

Drug: Yimitasvir Phosphate Capsule