Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

NCT ID: NCT05681273

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2023-03-21

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.

Conditions

T2DM

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chiglitazar

Intervention Type: DRUG

Chiglitazar 48mg

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10mg

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.

Group Type: EXPERIMENTAL

Chiglitazar

Intervention Type: DRUG

Chiglitazar 48mg

Atorvastatin

Intervention Type: DRUG

Atorvastatin 20mg

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.

Group Type: EXPERIMENTAL

Chiglitazar

Intervention Type: DRUG

Chiglitazar 48mg

Valsartan

Intervention Type: DRUG

Valsartan 160mg

Interventions

Chiglitazar

Chiglitazar 48mg

Intervention Type: DRUG

Empagliflozin

Empagliflozin 10mg

Intervention Type: DRUG

Atorvastatin

Atorvastatin 20mg

Intervention Type: DRUG

Valsartan

Valsartan 160mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chipscreen Biosciences, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongrong Xu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Zhongshan hospital

Shanghai, , China

Countries

China

Other Identifiers

CGZ110

Identifier Type: -

Identifier Source: org_study_id