Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.

This Phase 1 open label study is being conducted to characterize the pharmacokinetic (PK) and safety profiles of Chiglitazar with Empagliflozin，Atorvastatin and Valsartan in healthy subjects.

Study Overview

• Status: Completed
• Conditions: T2DM
• Intervention / Treatment: Drug: Chiglitazar; Drug: Empagliflozin; Drug: Atorvastatin; Drug: Valsartan

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male and female subjects between the ages of 18 and 45 years, inclusive;
• 19.0≤BMI≤26.0 kg/m2. Weight of male ≥50 kg and Weight of female ≥ 45 kg.

Exclusion Criteria:

• History of clinically significant allergy or atopic allergic disease, or allergy to the study drug;
• Previous surgery may affect drug absorption, distribution, metabolism and excretion; or have suffered from gastrointestinal, liver and kidney diseases that can affect drug absorption or metabolism in the past 6 months;
• History of tuberculosis;
• Frequent infection history in the past year, or serious infections leading to hospitalization within 3 months before administration;
• untreated diarrhea, or diarrhea within 7 days before administration;
• Any drugs, vitamin products or herbal medicine used within 1 month before administration;
• History of drug abuse;
• Participated in clinical trial within 3 months before administration;
• Blood donation or massive blood loss within 3 months before the first administration;
• Pregnant or lactating women;
• Regular drinking history; or took any alcoholic products within 48 hours before administration; or positive alcohol test;
• Regular smoking history within 3 months before administration or cannot quit smoking during the trial;
• GFR<80 mL/min;
• Abnormal results of laboratory examination,vital signs, 12 lead ECG, physical examination and chest X-ray;
• Systolic blood pressure<90 or ≥ 140 mmHg, diastolic blood pressure<60 or ≥ 90 mmHg;
• Other situations that are not suitable for participate the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; D1: Oral single dose of Empagliflozin 10 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Empagliflozin 10 mg and Chiglitazar 48 mg.	Drug: Chiglitazar; Chiglitazar 48mg; Drug: Empagliflozin; Empagliflozin 10mg
Experimental: Group B; D1: Oral single dose of Atorvastatin 20 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Atorvastatin 20 mg and Chiglitazar 48 mg.	Drug: Chiglitazar; Chiglitazar 48mg; Drug: Atorvastatin; Atorvastatin 20mg
Experimental: Group C; D1: Oral single dose of Valsartan 160 mg; D5~9: Oral multiple doses of Chiglitazar 48 mg; D10: Oral single dose of Valsartan 160 mg and Chiglitazar 48 mg.	Drug: Chiglitazar; Chiglitazar 48mg; Drug: Valsartan; Valsartan 160mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	up to 72 hours
AUC0-t and AUC0-inf	Area under of the curve (AUC0-t and AUC0-inf)	up to 72 hours

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.
• Investigators: Principal Investigator: Hongrong Xu, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Sodium-Glucose Transporter 2 Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Atorvastatin; Valsartan; Empagliflozin
• Other Study ID Numbers: CGZ110

Drug and device information, study documents

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