A Study to Evaluate the Pharmacokinetics of Apatinib in Subjects With Impaired Renal Function

Subjects With Impaired Renal Function and Healthy Subjects Clinical Trial

Official title:

A Multi-center, Non-randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetics of Apatinib Mesylate in Subjects With Impaired Renal Function and Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04414852
• Other study ID #: HR-APTN-I-011
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 5, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yuya Wang
• Phone: 13918749176
• Email: wangyuya[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to compare the pharmacokinetics of apatinib in subjects with impaired renal function and healthy subjects, to give dose recommendations for patients with impaired renal function.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: April 30, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

for subjects with impaired renal function

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

• 18-70 years of age.

• 19 kg/m2<BMI <19-28 kg/m2

• eGFR (MDRD equation) for mild impaired renal function: 60-89 mL/min/1.73 m2 eGFR (MDRD equation) for moderate impaired renal function: 30-59 mL/min/1.73 m2

• In good health, except for kidney disease and complications, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;

• 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;

for healthy subjects:

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

• 18-70 years of age.

• 19 kg/m2<BMI <19-28 kg/m2

• eGFR (MDRD equation) for mild impaired renal function: =90mL/min/1.73 m2

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

• 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;

Exclusion Criteria:

for subjects with renal impairment

• Renal allograft recipients;

• Need hemodialysis during study;

• Uroclepsia or anuria;

• Allergic to apatinib or ingredients;

• History of heart disease in 12 months before study;

• Coagulation disorders;

• Hypertension and could not be controlled with hypotensor;

• With hepatic or archenteric disease;

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

• Take any clinical trial drugs within 3 months prior dosing;

• Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days before dosing;

• Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit = 285 mL of beer, or 100mL of wine), or take =5 cigarettes;

• Positive in urine drug test;

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

• Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or grapefruit-containing products from 48 hours before dosing to the end of the study;

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

for healthy subjects:

• Renal allograft recipients;

• Allergic to apatinib or ingredients;

• History of heart disease in 12 months before study;

• Coagulation disorders;

• Hypertension and could not be controlled with hypotensor;

• With hepatic or archenteric disease;

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

• Take any clinical trial drugs within 3 months prior dosing;

• Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A in 14 days before dosing;

• Addicted to alcohol and tobacco, drinking 14 units of alcohol per week (1 unit =285 mL of beer, or 100mL of wine), or take =5 cigarettes;

• Positive in urine drug test;

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

• Anyone who refuse to stop ingesting drinks containing methylxanthine, or grapefruit or grapefruit-containing products from 48 hours before dosing to the end of the study;

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Subjects With Impaired Renal Function and Healthy Subjects

Intervention

Drug:
• Apatinib Mesylate
All the subjects will be administrated with 250mg apatinib on day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration	0-96 hours
Primary	AUC0-t	Area under the plasma concentration versus time curve from zero to 96h	0-96 hours
Primary	AUC0-8	Area under the plasma concentration versus time curve from zero to infinity	0-96 hours