Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

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Description

This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.

Targeted Conditions

Study Overview

Start Date
January 15, 2024
Completion Date
May 30, 2024
Enrollment
16
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
The First Affiliated Hospital of Xiamen University
Xiamen, China

Eligibility

Minimum Age (years)
15
Maximum Age (years)
65
Eligibility Criteria
Inclusion Criteria:

Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);

Ability to understand and willingness to sign a written informed consent form;

Participants with normal renal function only:

Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
Glomerular filtration rate (GFR)≥ 90 mL/min

Age, BMI, and sex comparable to those of subjects of severe renal impairment

Participants with severe renal impairment only:

Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months)
glomerular filtration rate (GFR) between 15-29 mL/min (including boundary)

Exclusion Criteria:

Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.
Pregnant or lactating women, or women of childbearing age with a positive pregnancy test

Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks

Participants with severe renal impairment only:

Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
New York heart association (NYHA) class III or IV congestive heart failure
Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;

Study Contact Info

Study Contact Name
Huang, Doctor
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06248567