Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Single-center, Two-sequence, Two- Stage Phase I Trial of Chiauranib Capsule on Pharmacokinetics to Assess the Effect of High Fat Diet in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346601
• Other study ID #: CAR 108
• Status: Completed
• Phase: Phase 1
• Start date: June 2, 2022
• Est. completion date: June 28, 2022

Study information

• Verified date: February 2023
• Source: Chipscreen Biosciences, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to further study the pharmacokinetic characteristics of Chiauranib Capsule in Healthy Volunteers with High Fat Diet.

Description:

This study is a Randomized, Open-label, Single-dose, Single-center, two-sequence, two- stage Phase I Trial. 16 Healthy Volunteers will be enrolled and Randomized into two arms. 8 Healthy Volunteers were in each arm. Arm A：Patients receive 50mg Chiauranib po only once In the fasting state and after 14 days receive 50mg Chiauranib po Only once with High Fat Diet. Arm B: Patients receive 50mg Chiauranib po only once with High Fat Diet and after 14 days receive 50mg Chiauranib po Only once In the fasting state. During the trial, Blood samples were collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Ages: 18 Years to 45 Years

2. 19=BMI=26. Weight of male =50 kg and Weight of female 45 kg

3. at screening Healthy or NCS as determined by the Investigator based on physical examination, vital signs, a series of laboratory examinations(such as blood routine examination, et.al)and 12-lead electrocardiogram (ECG)

4. Healthy Volunteers have no plan to fertilize throughout treatment and for at least 6 months after study is stopped

5. Healthy Volunteers voluntarily sign informed consent

6. Able to communicate well with the Investigator, to comply with the requirements of the study

Exclusion Criteria:

1. Has known allegies to Chiauranib ,any of the excipients or Have a history of relevant atopy or drug hypersensitivity

2. Being hypertension or having risk of hypertension, or SBP=140 mmHg, DBP =90 mmHg; or Being hypotension or having risk of hypotension, or SBP < 90 mmHg, DBP < 60 mmHg

3. Inability to take oral medication or having Gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism within 6 months

4. Prior to random Having uncured diarrhea or having 4 or more episodes of diarrhea within 7 days prior to scheduled drug administration

5. Having any significant history of hemorrhagic disease or any history of coagulopathy

6. A history of frequent and severe infection(=3 episodes)within the past 1 year, or a history of severe infection within 3 months prior to drug administration;

7. Ccr < 80 mL/min

8. Difficulty of venous blood collection

9. QTcF > 450 ms

10. Drug abuse within 5 years or used drug within 3 months prior to the study, or Urine drug screening is positive during screening

11. Heavy smokers(average daily smoking of more than 5 cigarettes/ day during past 3 months prior to screenig); heavy drinkers(average weekly drinking of more than 14 units of alcohol during past 6 months prior to screening, 1 unit =360 mL beer or 45 mL 40% spirits or 150 mL wine); Having Alcoholic products within 2 days prior to drug administration, or Alcohol breath test result =20 mg/dl

12. Ingestion of prescription drugs, OTC drug, Vitamin, dietary supplements or herbal products within 14 days prior to screening

13. Subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism(CYP3A, CYP1A2 and CYP2D6)within 30 days prior to drug administration of the study medication, or Subjects who have taken any foods and drinks known to induce or inhibit hepatic drug metabolism within 7 days prior to drug administration

14. Intake of Tea, Coffee or other Caffeinated beverage(more than 8 cups, 1 cup=250 mL)within 14 days prior to drug administration, Intake of any food or beverage containing or metabolized to produce caffeine or xanthine within 48 hours prior to drug administration

15. Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication

16. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test

17. The abnormal result of C-reactive protein has clinical significance or Subjects testing positive for COVID-19

18. Vaccinated within 1 month prior to screening or plan to Vaccinate during the study

19. Females with a positive pregnancy test or Women of childbearing potential, pregnant and lactating women

20. Volunteer in any other study within 3 months prior to drug administration, or Volunteer in 3 times or more studies

21. Blood donation or lost more than 400mL blood within 3 months prior to the study, or Received blood transfusions within 1 month

22. Patients received major surgical operations within 6 months prior to screening, or plan to received surgical operation during the study

23. Extremes in food consumption practices

24. Other situations that the researchers considered unsuitable to enroll the subject

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Chiauranib
50mg po only once

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Chipscreen Biosciences, Ltd.	H & J CRO International, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Chiauranib (in plasma)	Peak plasma concentration for Chiauranib(Cmax)	up to 20 Days
Primary	Pharmacokinetics of Chiauranib (in plasma)	Area under the concentration-time curve from zero to last quantificable concentration for Chiauranib (AUC0-t)	up to 20 Days
Primary	Pharmacokinetics of Chiauranib (in plasma)	Area under the concentration-time curve from zero extrapolated to infinity for Chiauranib(AUC0-inf)	up to 20 Days
Secondary	Pharmacokinetics of Chiauranib (in plasma)	Time to Cmax for Chiaruanib(Tmax)	up to 20 Days
Secondary	Pharmacokinetics of Chiauranib (in plasma)	Elimination half-life(t1/2)	up to 20 Days
Secondary	Pharmacokinetics of Chiauranib (in plasma)	Apparent clearance(CL/F)	up to 20 Days
Secondary	Pharmacokinetics of Chiauranib (in plasma)	Apparent volume of distribution(Vd/F)	up to 20 Days
Secondary	Pharmacokinetics of Chiauranib (in plasma)	Elimination rate constant(?z)	up to 20 Days