Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

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

Official Title
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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

Conditions
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Hepatic Impairment, Pharmacokinetics

Intervention / Treatment
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* Drug: ZSP1273
* Drug: ZSP1273
* Drug: ZSP1273


Participation Criteria
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Eligibility Criteria
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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. Participants (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: 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. QTcF (male) > 470ms，QTcF (female) > 480ms Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks 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 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with drug-related adverse events as assessed by CTCAE v5.0 |  | Day 1 to Day12 |