Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Pharmacokinetics

Treatments: Drug: ZSP1273

Study type: Interventional

Funder types: Industry

Identifiers

NCT05856513

ZSP1273-23-12

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Child-Pugh A

Experimental group

Description:

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

Treatment:

Drug: ZSP1273

Drug: ZSP1273

Drug: ZSP1273

Child-Pugh B

Experimental group

Description:

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

Treatment:

Drug: ZSP1273

Drug: ZSP1273

Drug: ZSP1273

Normal hepatic function

Experimental group

Description:

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

Treatment:

Drug: ZSP1273

Drug: ZSP1273

Drug: ZSP1273