Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

Phase 1

Completed

• Conditions: T2DM
• Interventions: Drug: Chiglitazar; Drug: Empagliflozin; Drug: Atorvastatin; Drug: Valsartan

• Registration Number: NCT05681273
• Lead Sponsor: Chipscreen Biosciences, Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-12
• Study Start: 2023-02-17
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Chiglitazar	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.
Group A	Chiglitazar	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.
Group C	Chiglitazar	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.
Group A	Empagliflozin	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.
Group B	Atorvastatin	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.
Group C	Valsartan	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.

Primary Outcome Measures

Name	Time	Method
Cmax	up to 72 hours	Maximum plasma concentration
AUC0-t and AUC0-inf	up to 72 hours	Area under of the curve (AUC0-t and AUC0-inf)

Trial Locations

Locations (1)

Zhongshan hospital; 🇨🇳 Shanghai, China