Clinical trial NCT04341090: A Food Effect Study of Apatinib Mesylate in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
measure: AUC0-t
timeFrame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
measure: AUC0-inf
timeFrame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
Study officials:
References: