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

NCT05515458 | Completed Phase 1

• 1 other identifier: CGZ109
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 renal impairment compared to subjects with normal renal function.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration

  4 days

• AUC0-t and AUC0-inf

  Area under of the curve (AUC0-t and AUC0-inf)

  4 days

Study Arms (2)

Normal Renal Function

EXPERIMENTAL

Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar

Drug: Chiglitazar

Severe Renal Impairment

EXPERIMENTAL

Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar

Drug: Chiglitazar

Interventions

Chiglitazar DRUG

Oral single dose 48 mg

Normal Renal Function; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign informed consent, able to comply with the requirements of the study.
• Male or female, between 18 and 79 years of age.
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

chiglitazar

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• LiYan Miao

  First Affiliated Hospital of Suzhou Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: November 20, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)