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
Verified date | September 2020 |
Source | Sunshine Lake Pharma Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma Co., Ltd. |
China,
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 |
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