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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04565171

Enrollment

Registered

2020-09-25

Start date

2021-04-15

Completion date

2022-05-07

Last updated

2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

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.

Interventions

DRUGYimitasvir Phosphate Capsule

DAG181 100 mg (100 mg Capsule) administered orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by AUC	From Days 1-5	AUC is defined as the concentration of drug area under the curve
Plasma pharmacokinetics (PK) parameters of DAG181 as measured by Cmax	From Days 1-5	Cmax is defined as the maximum concentration of drug

Secondary

Measure	Time frame	Description
Incidence of adverse events	From Days 1-5	The incidence of adverse events will be summarized

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026