The purpose of this study is to characterize the pharmacokinetics of HQP1351 in participants with resistant chronic myeloid leukemia (CML) in chronic phase (CP) after high-fat and fasting meals separately(Selection of high-fat meal spectrum:《The Food - Effect Bioavailability and Fed Bioequivalence Studies》high fat diet should be 800-1000 kcal heat.).
The drug being test in this study is HQP1351,the study will characterize the pharmacokinetics of HQP1351 in participants with resistant chronic myeloid leukemia(CML)in chronic phase(CP)after high-fat meal and fasting meal separately at a dose of 30mg,single-dose. The study will enroll 12 subjects totally and be randomly divided into 2 groups(A group and B group). Every group will have 6 subjects. The experiment is divided into two periods,in period 1, subjects in the group A will be given HQP1351 30mg after fasting meal,and the group B will be given HQP1351 30mg after 30 minutes of high-fat meal. Then after a seven-day of cleaning time the two groups of subjects took the drug interchangeably in the period 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Orally, single dose of 30mg on day 1 and day 8.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Area under the curve from the time of dosing to infinity [AUC(0-inf)]
Area under the plasma concentration-time curve from time zero extrapolated to infinity time of HQP1351.
Time frame: 1-5 days after every drug administration
Area under the curve from the time of dosing to the last measurable concentration [AUC(0-last)]
Area under the plasma concentration-time curve from time zero to the last measurable time point of HQP1351.
Time frame: 1-5 days after every drug administration
Percentage of AUC(0-inf)_obs due to extrapolation from the last measurable time point to infinity (AUC_%Extrap)
Percentage of area under the concentration time curve from time zero extrapolated to infinite time obtained by extrapolation of HQP1351.
Time frame: 1-5 days after every drug administration
Maximum observed concentration (Cmax)
Maximum observed plasma concentration of HQP1351.
Time frame: 1-5 days after every drug administration
Time of maximum observed concentration (Tmax)
Time to maximum observed plasma concentration of HQP1351.
Time frame: 1-5 days after every drug administration
Terminal elimination half life (T1/2)
Terminal elimination half life (T1/2) is defined as the duration until observation of half of the maximum concentration of HQP1351.
Time frame: 1-5 days after every drug administration
Total body clearance for extravascular administration (CL/F)
Apparent clearance of HQP1351 following oral dosing. Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose of HQP1351 (apparent oral clearance) is influenced by the fraction of dose absorbed.
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Time frame: 1-5 days after every drug administration
Volume of distribution based on the terminal phase for extravascular administration (Vz/F)
Apparent volume of distribution of HQP1351. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution of HQP1351 after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 1-5 days after every drug administration
Incidence of toxicity
Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time frame: up to 12 days