Clinical trial NCT04414852: A Study to Evaluate the Pharmacokinetics of Apatinib in Subjects With Impaired Renal Function
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Subjects With Impaired Renal Function and Healthy Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Cmax
timeFrame: 0-96 hours
measure: AUC0-t
timeFrame: 0-96 hours
measure: AUC0-∞
timeFrame: 0-96 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: