Clinical trial NCT05856513: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Pharmacokinetics
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Day 1 to Day 6
measure: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Day 1 to Day 6
measure: Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
timeFrame: Day 1 to Day 6
Secondary outcomes:
measure: Number of participants with drug-related adverse events as assessed by CTCAE v5.0
timeFrame: Day 1 to Day12
Other outcomes:
Locations:
city: Jilin
country: China
facility: The First Hospital of Jilin University
Study officials:
References: