Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

Kidney Impairment Clinical Trial

Official title:

A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Severe Kidney Impairment on the Pharmacokinetics, Safety and Tolerability of ZSP1273

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248567
• Other study ID #: ZSP1273-23-14
• Status: Recruiting
• Phase: Phase 1
• Start date: January 15, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: January 2024
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: Huang, Doctor
• Phone: 0592-7212601
• Email: hjy0602[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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);

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

Participants with normal renal function only:

3. 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.

4. Glomerular filtration rate (GFR)= 90 mL/min

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

Participants with severe renal impairment only:

6. Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months)

7. glomerular filtration rate (GFR) between 15-29 mL/min (including boundary)

Exclusion Criteria:

1. 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.

2. Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.

3. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test

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

Participants with severe renal impairment only:

5. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;

6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure = 160mm Hg or diastolic blood pressure = 100mm Hg)

7. New York heart association (NYHA) class III or IV congestive heart failure

8. Alanine aminotransferase (ALT) = 2×ULN, aspartate aminotransferase(AST) = 2×ULN; Serum total bilirubin > 1.5×ULN;

Related Conditions & MeSH terms

• Kidney Impairment
• Renal Insufficiency

Intervention

Drug:
• ZSP1273
Oral

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)	The Cmax of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.	0~120hours
Primary	Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)	The AUClast of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.	0~120hours
Secondary	Number of participants with drug-related adverse events as assessed by CTCAE v5.0		DAY1~DAY12