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

NCT ID: NCT04414852

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2021-04-30

Brief 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.

Conditions

Subjects With Impaired Renal Function and Healthy Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mild renal impairment

Group Type: EXPERIMENTAL

Apatinib Mesylate

Intervention Type: DRUG

All the subjects will be administrated with 250mg apatinib on day 1

moderate remal impairment

Group Type: EXPERIMENTAL

Apatinib Mesylate

Intervention Type: DRUG

All the subjects will be administrated with 250mg apatinib on day 1

normal renal impairment

Group Type: ACTIVE_COMPARATOR

Apatinib Mesylate

Intervention Type: DRUG

All the subjects will be administrated with 250mg apatinib on day 1

Interventions

Apatinib Mesylate

All the subjects will be administrated with 250mg apatinib on day 1

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yuya Wang

Role: CONTACT

wangyuya@hrglobe.cn

13918749176

Other Identifiers

HR-APTN-I-011

Identifier Type: -

Identifier Source: org_study_id