Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function

Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function

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 renal impairment compared to subjects with normal renal function.

Study Overview

• Status: Recruiting
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: Chiglitazar

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.
• the absolute eGFR must meet standard in renal function classification.
• 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, and serum potassium ≥3.5 mmol/L and ≤5.5 mmol/L.

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.
• suffer from uncontrolled serious diseases of heart failure/hypertension, respiratory, liver, 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 within 5 years before screening., 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.
• 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 have received blood products.
• Acute hepatitis, chronic liver disease, or any one of ALT, AST, and total bilirubin is greater than 2 times the upper limit of normal.
• HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.
• Female subjects who are breastfeeding or positive test of serum pregnancy.
• Other circumstances assessed by the investigator are not suitable for participating in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal Renal Function; Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar	Drug: Chiglitazar; Oral single dose 48 mg
Experimental: Severe Renal Impairment; Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar	Drug: Chiglitazar; Oral single dose 48 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	4 days
AUC0-t and AUC0-inf	Area under of the curve (AUC0-t and AUC0-inf)	4 days

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: CGZ109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No