Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Hepatic Impairment
• Intervention / Treatment: Drug: ZSP1273

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin, China
    • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participant must be ≥ 18 to ≤ 68 years, at the time of signing the informed consent.
2. BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2.
3. Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product.

4. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

   Participants with hepatic impairment only:

5. Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
6. Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants

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. QTcF (male) > 470ms，QTcF (female) > 480ms
3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
4. Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months.
5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test

6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening

   Participants with Normal Hepatic Function Only:

7. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.

   Participants with Hepatic Impairment Only:

8. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratoryor hematological, immune, psychiatric, and metabolic disorders.
9. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Child-Pugh A; 8 participants with mild hepatic impairment (Child-Pugh A) will be given 600mg of ZSP1273.	Drug: ZSP1273; Participants receive ZSP1273 orally.
Experimental: Child-Pugh B; 8 participants with moderate hepatic impairment (Child-Pugh B) will be given 600mg of ZSP1273.	Drug: ZSP1273; Participants receive ZSP1273 orally.
Experimental: Normal hepatic function; 8 participants with normal hepatic function will be given 600mg of ZSP1273.	Drug: ZSP1273; Participants receive ZSP1273 orally.

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 impaired hepatic function and controls with normal hepatic function will be evaluated and compared.	Day 1 to Day 6
Area under the concentration-time curve from time zero to infinity (AUCinf)	The AUCinf of a single dose of ZSP1273 in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.	Day 1 to Day 6
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 impaired hepatic function and controls with normal hepatic function will be evaluated and compared.	Day 1 to Day 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with drug-related adverse events as assessed by CTCAE v5.0	Day 1 to Day12

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): July 4, 2023
• Study Completion (Actual): July 4, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ZSP1273-23-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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