Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease

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

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Impairment
• Intervention / Treatment: Drug: ZSP1273

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huang, Doctor; Phone Number: 0592-7212601; Email: hjy0602@163.com

Study Locations

• China
  • Xiamen, China
    • Recruiting
    • The First Affiliated Hospital of Xiamen University
    • Contact: Huang, Doctor; Phone Number: 0592-7212601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 1: participants with severe renal impairment; 8 participants with severe renal impairment will be given 600mg of ZSP1273	Drug: ZSP1273; Oral
Experimental: Experimental 2: healthy participants; 8 participants with normal renal function will be given 600mg of ZSP1273	Drug: ZSP1273; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with drug-related adverse events as assessed by CTCAE v5.0	DAY1~DAY12

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: ZSP1273-23-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No