Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

T2DM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05681273
• Other study ID #: CGZ110
• Status: Completed
• Phase: Phase 1
• Start date: February 17, 2023
• Est. completion date: March 21, 2023

Study information

• Verified date: December 2022
• Source: Chipscreen Biosciences, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• T2DM

Intervention

Drug:
• Chiglitazar
Chiglitazar 48mg
• Empagliflozin
Empagliflozin 10mg
• Atorvastatin
Atorvastatin 20mg
• Valsartan
Valsartan 160mg

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chipscreen Biosciences, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration	up to 72 hours
Primary	AUC0-t and AUC0-inf	Area under of the curve (AUC0-t and AUC0-inf)	up to 72 hours