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Completed

NCT Number: NCT05681273

Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects.

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chiglitazar

Drug

Chiglitazar 48mg

Empagliflozin

Drug

Empagliflozin 10mg

atorvastatin

Drug

Atorvastatin 20mg

valsartan

Drug

Valsartan 160mg

Primary outcomes

  1. Cmax

    Time frame: up to 72 hours

    Maximum plasma concentration

  2. AUC0-t and AUC0-inf

    Time frame: up to 72 hours

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

Sponsors and collaborators

Lead sponsor

Chipscreen Biosciences, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.