Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

Chipscreen Biosciences

Status and phase: Completed; Phase 1

Conditions: T2DM

Treatments: Drug: Atorvastatin; Drug: Valsartan; Drug: Chiglitazar; Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05681273

CGZ110

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Drug: Empagliflozin

Drug: Chiglitazar

Group B

Experimental group

Description:

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.

Treatment:

Drug: Atorvastatin

Drug: Chiglitazar

Group C

Experimental group

Description:

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.

Treatment:

Drug: Valsartan

Drug: Chiglitazar