Clinical trial NCT05515445: Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
Official title: Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Chipscreen Biosciences, Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.


Eligibility criteria: Inclusion Criteria:

* Voluntarily sign informed consent, able to comply with the requirements of the study.
* Male or female, between 18 and 79 years of age.
* 18≤BMI≤30. Weight of male ≥50 kg and Weight of female ≥ 45 kg.
* No medication within 2 weeks, or stable medication for at least 4 weeks prior to screening.
* Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory test have been determined by the investigator to be suitable for participating in this trial.

Exclusion Criteria:

* Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.
* received PPAR agonist drugs within 2 weeks before screening.
* Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.
* positive test for COVID-19, TP antibody and RPR, or HIV antibody.
* suffer from uncontrolled serious diseases of cardiovascular, respiratory, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before screening.
* have previously undergone surgery that may affect the absorption, distribution, metabolism, and excretion of drugs; anticipate surgery or hospitalization during the trial.
* Drug abusers, or positive test for drugs of abuse.
* Smoking more than 5 cigarettes per day on average within 3 months before screening.
* The average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: more than 14 g for women, or more than 28 g for men; ingested any products containing alcohol within 48 hours before administration; positive alcohol breath test; patients with alcoholic cirrhosis who did not abstinence within 3 months before screening.
* Ingestion of grapefruit juice/grapefruit juice, food or drink rich in methylxanthine within 48 hours before administration; strenuous exercise or other factors that affect drug absorption, distribution, metabolism, excretion.
* participated in clinical trials of any drug or medical device within 3 months before screening.
* donated blood (or blood loss) ≥400 mL within 3 months before screening, or received whole blood or red blood cell suspension.
* Female subjects who are breastfeeding or positive test of serum pregnancy.
* eGFR\<60 mL/min/1.73m2.
* Other circumstances assessed by the investigator are not suitable for participating in this trial.

Supplementary exclusion criteria for subjects with hepatic impairment：

* drug-induced liver injury.
* acute liver function damage caused by various reasons;
* complications of liver cirrhosis that the investigator considers inappropriate to participate in the study.
* diseases that seriously affect bile excretion.

Supplementary exclusion criteria for subjects with normal hepatic function:

* history of hepatic function damage, or who may have hepatic function damage that the investigator considers to be clinically significant.
* positive test for HBsAg, HCV.

Primary outcomes:
measure: Cmax
timeFrame: 4 days
measure: AUC0-t and AUC0-inf
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Suzhou Medical College
name: LiYan Miao
role: PRINCIPAL_INVESTIGATOR
References: