Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

NCT05681273 | Completed Phase 1

• 1 other identifier: CGZ110
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Group A

EXPERIMENTAL

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; Drug: Empagliflozin

Group B

EXPERIMENTAL

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; Drug: Atorvastatin

Group C

EXPERIMENTAL

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; Drug: Valsartan

Interventions

Chiglitazar DRUG

Chiglitazar 48mg

Group A; Group B; Group C

Empagliflozin DRUG

Empagliflozin 10mg

Group A

Atorvastatin DRUG

Atorvastatin 20mg

Group B

Valsartan DRUG

Valsartan 160mg

Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Zhongshan hospital

Shanghai, China

Location

MeSH Terms

Interventions

chiglitazar; empagliflozin; Atorvastatin; Valsartan

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Tetrazoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Hongrong Xu

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: February 17, 2023
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: June 15, 2023

Record last verified: 2022-12

Locations

CN (1)