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| Name | Class |
|---|---|
| HealthQuest Pharma Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental | Subjects in the group A will be given HQP1351 after fasting meal on Day 1. Then after a seven-day of cleaning time, subjects in the group A will be given HQP1351 after 30 minutes of high-fat meal on Day 8. |
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| B group | Experimental | Subjects in the group B will be given HQP1351 after 30 minutes of high-fat meal on Day 1. Then after a seven-day of cleaning time, subjects in the group B will be given HQP1351 after fasting meal on Day 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HQP1351 | Drug | Orally, single dose of 30mg on day 1 and day 8. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1-5 days after every drug administration |
| Maximum observed concentration (Cmax) | Maximum observed plasma concentration of HQP1351. | 1-5 days after every drug administration |
| Time of maximum observed concentration (Tmax) | Time to maximum observed plasma concentration of HQP1351. | 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. | 1-5 days after every drug administration |
| Total body clearance for extravascular administration (CL/F) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of toxicity | Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 | up to 12 days |
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Inclusion Criteria:
Male or non-pregnant, non-lactating female patients age 18-55 years old.
CML Patients in CP with Ph-positive or BCR/ABL-positive.
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.
Ability to understand and willingness to sign a written informed consent form. The consent form must be signed by the patient prior to any study-specific procedures.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Predicted life expectancy of ≥3 months.
Organ function as indicated by the following laboratory indicators must be met:
Cardiac function index: ejection fraction (EF) > 50%.
Corrected QT interval (QTc) interval on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females.
Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential and their partners throughout the treatment period and for at least 120 days following the last dose of study drug.
Willingness and ability to comply with study procedures and follow-up examination.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| QIAN JIANG, Professor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C579813 | olverembatinib |
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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. |
| 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. | 1-5 days after every drug administration |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |