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

NCT04414852 | Unknown Phase 1

• 1 other identifier: HR-APTN-I-011
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum plasma concentration

  0-96 hours

• AUC0-t

  Area under the plasma concentration versus time curve from zero to 96h

  0-96 hours

• AUC0-∞

  Area under the plasma concentration versus time curve from zero to infinity

  0-96 hours

Study Arms (3)

mild renal impairment

EXPERIMENTAL

Drug: Apatinib Mesylate

moderate remal impairment

EXPERIMENTAL

Drug: Apatinib Mesylate

normal renal impairment

ACTIVE COMPARATOR

Drug: Apatinib Mesylate

Interventions

Apatinib Mesylate DRUG

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

mild renal impairment; moderate remal impairment; normal renal impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for subjects with impaired renal function
• Able to comprehend and willing to sign an informed consent form (ICF)
• years of age.
• 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)
• years of age.
• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Interventions

apatinib

Central Study Contacts

Yuya Wang

CONTACT

13918749176; wangyuya@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 5, 2020
• Primary Completion: January 15, 2021
• Study Completion: April 30, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-06