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Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia

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

NCT03882281•Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

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.).

Detailed Description

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or non-pregnant, non-lactating female patients age 18-55 years old.
•2. CML Patients in CP with Ph-positive or BCR/ABL-positive.
•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.
•4. 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.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
•6. Predicted life expectancy of ≥3 months.
•7. Organ function as indicated by the following laboratory indicators must be met:
•* Hemoglobin ≥8.0g/dL.
•* White blood cell count ≥ 3.0×10\^9/L, neutrophil count≥ 1.5 x 10\^9/L.
•* Platelet count ≥ 75×10\^9/L.
+10 more criteria

Exclusion Criteria

•1. Received cytotoxic chemotherapy or radiotherapy within 28 days, interferon or cytarabine within 14 days, any investigational therapy within 14 days prior to the first dose of study drug, or have not recovered (\> grade 1 by NCI CTCAE v 4.03) from adverse events (AEs ) (except alopecia) due to agents previously administered.
•2. Require concurrent treatment with drugs that may have interactions with the study drug.
•3. Have previously been treated with ponatinib (or drugs of similar composition).
•4. Absorption disorder syndrome or other diseases affecting oral drug absorption.
•5. Have any history of heart or vascular disease, such as hypertension (systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90mmHg), or take medications that are known to cause prolonged ECG QT interval.
•6. Mean pulmonary artery pressure \>25 mmHg.
•7. Have a history of serious cardiovascular diseases during the previous treatment of chronic myeloid leukemia with TKI.
•8. Underwent autologous or allogeneic stem cell transplant.
•9. Abnormal coagulation function，or have a bleeding disorder within 3 months before first administration.
•10. Underwent major surgery (with the exception of minor surgical procedures, such as placement or bone marrow biopsy) with 14 days prior to first dose of study drug.
+7 more criteria

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 25, 2019

Primary Completion Date

November 16, 2019

Completion Date

November 16, 2019

Last Updated

January 22, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Interventions

HQP1351

DRUG

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

NCT06119269

Chronic Myeloid Leukemia, Chronic Phase

View study

COMPLETEDPHASE2

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

NCT04126681

Chronic Myeloid Leukemia, Chronic Phase

View study

COMPLETED

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase

A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase

Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

Nilotinib for First-line Newly Diagnosed CML-CP Patients