Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05856513
• Other study ID #: ZSP1273-23-12
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2023
• Est. completion date: July 4, 2023

Study information

• Verified date: November 2023
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 4, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases
• Pharmacokinetics

Intervention

Drug:
• ZSP1273
Participants receive ZSP1273 orally.
• ZSP1273
Participants receive ZSP1273 orally.
• ZSP1273
Participants receive ZSP1273 orally.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of participants with drug-related adverse events as assessed by CTCAE v5.0		Day 1 to Day12