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Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

Sponsor
Chipscreen Biosciences, Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05681273
Collaborator
(none)
48
Enrollment
3
Arms
1.6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study to Evaluate the Drug-Drug Interaction of Chiglitazar With Empagliflozin，Atorvastatin and Valsartan in Healthy Subjects.
Anticipated Study Start Date :
Feb 9, 2023
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Chiglitazar
Chiglitazar 48mg

Drug: Empagliflozin
Empagliflozin 10mg
Experimental: 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.

Drug: Chiglitazar
Chiglitazar 48mg

Drug: Atorvastatin
Atorvastatin 20mg
Experimental: 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.

Drug: Chiglitazar
Chiglitazar 48mg

Drug: Valsartan
Valsartan 160mg

Outcome Measures

Primary Outcome Measures

  1. Cmax [up to 72 hours]

    Maximum plasma concentration

  2. AUC0-t and AUC0-inf [up to 72 hours]

    Area under of the curve (AUC0-t and AUC0-inf)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 infection history 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chipscreen Biosciences, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier:
NCT05681273
Other Study ID Numbers:
  • CGZ110
First Posted:
Jan 12, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Empagliflozin
Valsartan
Atorvastatin

Study Results

No Results Posted as of Jan 12, 2023