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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04414852
Phase
PHASE1
Status
Unknown

Conditions

  • Subjects With Impaired Renal Function and Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 5, 2020
Status verified
Jun 2020
Primary completion
Jan 15, 2021
Completion
Apr 30, 2021

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: mild renal impairment
  • Experimental: moderate remal impairment
  • Active Comparator: normal renal impairment

Primary Outcome Measure

Cmax [ Time Frame: 0-96 hours ]

Central Contacts