A Food Effect Study of Apatinib Mesylate in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Three-period, Six-sequences, Crossover Study of High-fat and Low-fat Meal Effect on the Pharmacokinetics of Apatinib Mesylate in Chinese Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341090
• Other study ID #: HR-APTN-I-009
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2020
• Est. completion date: July 6, 2020

Study information

• Verified date: October 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects. The secondary objective of the study was to assess the safety of apatinib mesylate administered in adult healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. 18-45 years of age, male or female, each gender should be more than 1/4 of the whole sample size.

2. The weight of male subject =50kg, weight of female subject =45kg, 19=BMI=28kg/m2

3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;

4. Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;

5. Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion Criteria:

1. History of drug allergy, or allergic to apatinib or ingredients;

2. Drinking 14 units of alcohol per week within 6 months prior dosing(1 unit = 360 mL of beer, or 150mL of wine) ;

3. Take any prescription or traditional Chinese medicines within four weeks prior dosing; take any over-the-counter medication, vitamin products within two weeks before dosing;

4. Take any clinical trial drugs within 3 months prior dosing;

5. Participate in blood donation within 3 months before screening and donate blood volume =400mL or blood loss =400mL, or receive blood transfusion; or donate blood volume=200mL or blood loss =200mL within 1 month prior dosing.

6. Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;

7. Anyone who refuse to stop ingest foods or drinks containing caffeine, xanthine or alcohol from 48 hours before dosing to the end of the study;

8. Anyone who refuse to stop ingesting grapefruit or grapefruit-containing products from 7 days before dosing to the end of the study;

9. The investigator believes that the subjects are not eligible to participate in this trial.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Apatinib Mesylate
Single dose of apatinib mesylate after high-fat meal, low fat meal and fast

Locations

Country	Name	City	State
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum Observed Plasma Concentration for apatinib [ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours ]	Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Primary	AUC0-t	Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib	Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Primary	AUC0-inf	Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib	Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours