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Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

Primary Purpose

Hepatic Impairment, Pharmacokinetics

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ZSP1273
ZSP1273
ZSP1273
Sponsored by
Guangdong Raynovent Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Impairment

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant must be ≥ 18 to ≤ 68 years, at the time of signing the informed consent. BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2. Participates (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product. 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: Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available. 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: Participates 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. QTcF (male) > 470ms,QTcF (female) > 480ms Participates with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks Participates 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 Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening Participants with Normal Hepatic Function Only: 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: 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. Participates 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

Sites / Locations

  • The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Child-Pugh A

Child-Pugh B

Normal hepatic function

Arm Description

8 participants with mild hepatic impairment (Child-Pugh A) will be given 600mg of ZSP1273.

8 participants with moderate hepatic impairment (Child-Pugh B) will be given 600mg of ZSP1273.

8 participants with normal hepatic function will be given 600mg of ZSP1273.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Number of participants with drug-related adverse events as assessed by CTCAE v5.0

Full Information

First Posted
May 4, 2023
Last Updated
July 17, 2023
Sponsor
Guangdong Raynovent Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05856513
Brief Title
Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
July 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Raynovent Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Pharmacokinetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child-Pugh A
Arm Type
Experimental
Arm Description
8 participants with mild hepatic impairment (Child-Pugh A) will be given 600mg of ZSP1273.
Arm Title
Child-Pugh B
Arm Type
Experimental
Arm Description
8 participants with moderate hepatic impairment (Child-Pugh B) will be given 600mg of ZSP1273.
Arm Title
Normal hepatic function
Arm Type
Experimental
Arm Description
8 participants with normal hepatic function will be given 600mg of ZSP1273.
Intervention Type
Drug
Intervention Name(s)
ZSP1273
Intervention Description
Participants receive ZSP1273 orally.
Intervention Type
Drug
Intervention Name(s)
ZSP1273
Intervention Description
Participants receive ZSP1273 orally.
Intervention Type
Drug
Intervention Name(s)
ZSP1273
Intervention Description
Participants receive ZSP1273 orally.
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Description
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.
Time Frame
Day 1 to Day 6
Title
Area under the concentration-time curve from time zero to infinity (AUCinf)
Description
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.
Time Frame
Day 1 to Day 6
Title
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
Description
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.
Time Frame
Day 1 to Day 6
Secondary Outcome Measure Information:
Title
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time Frame
Day 1 to Day12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant must be ≥ 18 to ≤ 68 years, at the time of signing the informed consent. BMI ≥ 18 kg/m2 up to ≤ 32 kg/m2. Participates (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product. 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: Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available. 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: Participates 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. QTcF (male) > 470ms,QTcF (female) > 480ms Participates with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks Participates 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 Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening Participants with Normal Hepatic Function Only: 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: 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. Participates 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
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Jilin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

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