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Report for Clinical Trial NCT03882281

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Open, Double-crossing Trial to Evaluate the Effect of Fasting or High-fat Meals on the Pharmacokinetics of Single Oral Administration of HQP1351 Tablets on an Empty Stomach or a High-fat Meal in Patients With Chronic Myeloid Leukemia

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.).

NCT03882281 Chronic Myeloid Leukemia, Chronic Phase
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: HQP1351

Description: Orally, single dose of 30mg on day 1 and day 8.
Type: Drug
Group Labels: 2

A group B group


Primary Outcomes

Description: Area under the plasma concentration-time curve from time zero extrapolated to infinity time of HQP1351.

Measure: Area under the curve from the time of dosing to infinity [AUC(0-inf)]

Time: 1-5 days after every drug administration

Description: Area under the plasma concentration-time curve from time zero to the last measurable time point of HQP1351.

Measure: Area under the curve from the time of dosing to the last measurable concentration [AUC(0-last)]

Time: 1-5 days after every drug administration

Description: Percentage of area under the concentration time curve from time zero extrapolated to infinite time obtained by extrapolation of HQP1351.

Measure: Percentage of AUC(0-inf)_obs due to extrapolation from the last measurable time point to infinity (AUC_%Extrap)

Time: 1-5 days after every drug administration

Description: Maximum observed plasma concentration of HQP1351.

Measure: Maximum observed concentration (Cmax)

Time: 1-5 days after every drug administration

Description: Time to maximum observed plasma concentration of HQP1351.

Measure: Time of maximum observed concentration (Tmax)

Time: 1-5 days after every drug administration

Description: Terminal elimination half life (T1/2) is defined as the duration until observation of half of the maximum concentration of HQP1351.

Measure: Terminal elimination half life (T1/2)

Time: 1-5 days after every drug administration

Description: 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.

Measure: Total body clearance for extravascular administration (CL/F)

Time: 1-5 days after every drug administration

Description: 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.

Measure: Volume of distribution based on the terminal phase for extravascular administration (Vz/F)

Time: 1-5 days after every drug administration

Secondary Outcomes

Description: Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Measure: Incidence of toxicity

Time: up to 12 days

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 T315I

3. Previously treated with and or developed resistance / intolerance to second generation tyrosine kinase inhibitors (TKIs) (dasatinib,nilotinib)or,been identified to have the T315I mutation at any time during treatment. --- T315I ---



HPO Nodes


HPO: