Chronic Myeloid Leukemia, Chronic PhasePhase 1CMLNCT03882281
Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia
A Phase 1 study testing HQP1351 in people with Chronic Myeloid Leukemia, Chronic Phase, run by Ascentage Pharma Group Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- What is being tested?
- HQP1351
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2019to 16 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
- Serum creatinine ≤ 1.5×upper limit of normal (ULN) or 24 hours calculated creatinine clearance ≥ 50ml/min when serum creatinine >1.5×ULN.
- Serum albumin≥ 3.0 g/dL.
- Total bilirubin ≤ 1.5 x ULN.
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN of institution's normal range.
- Lipase≤1.5×ULN, Amylase≤1.5×ULN.
- Prothrombin time (PT), activated partial thromboplastin time (APTT), INR≤1.5×ULN.
- 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.
Who cannot join
- 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.
- Require concurrent treatment with drugs that may have interactions with the study drug.
- Have previously been treated with ponatinib (or drugs of similar composition).
- Absorption disorder syndrome or other diseases affecting oral drug absorption.
- 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.
- Mean pulmonary artery pressure >25 mmHg.
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- Have a history of serious cardiovascular diseases during the previous treatment of chronic myeloid leukemia with TKI.
- Underwent autologous or allogeneic stem cell transplant.
- Abnormal coagulation function，or have a bleeding disorder within 3 months before first administration.
- 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.
- Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
- Have active nervous system (CNS) disease as evidence by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required.
- History of primary malignancy (cured for more than 5 years, completely resected superficial skin cancer other than melanoma, adequately treated in-situ cancer, or controlled prostate cancer will not be considered exclusionary).
- Active symptomatic infection.
- Known to be allergic to study drug ingredients or their analogues.
- Are pregnant or lactating or expecting pregnancy during the study program.
- Suffer from any condition or illness that, in the opinion of the Investigator or the sponsor, would compromise patient safety or interfere with the evaluation of the safety of the study drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: 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.).
Read the 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.
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Being tested
- HQP1351
- Keywords
- Chronic Myeloid Leukemia, Chronic Phase, HQP1351
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HQP1351Drug
Orally, single dose of 30mg on day 1 and day 8.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HQP1351 |
| 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. Receives: Drug: HQP1351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-5 days after every drug administration
Maximum observed concentration (Cmax)
Maximum observed plasma concentration of HQP1351.
Measured: 1-5 days after every drug administration
Time of maximum observed concentration (Tmax)
Time to maximum observed plasma concentration of HQP1351.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-5 days after every drug administration
Secondary outcomes (1)
Incidence of toxicity
Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Measured: up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start25 Mar 2019
- Primary completion16 Nov 2019
- Study completion16 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthQuest Pharma Inc.
- Responsible party
- Sponsor
- Investigators
- QIAN JIANG, Professor, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882281
- Sponsor's protocol ID
- HQP1351LC104
- Acronym
- CML
- Status last verified
- Jan 2020
- First submitted
- 12 Mar 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03882281
- Acronym / sponsor ID
- CML / HQP1351LC104
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Keywords
- Chronic Myeloid Leukemia, Chronic Phase, HQP1351
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- HealthQuest Pharma Inc.
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 16 Nov 2019 (actual)
- Study completion
- 16 Nov 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: HQP1351Subjects 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. |
| B group | Experimental | Drug: HQP1351Subjects 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- Require concurrent treatment with drugs that may have interactions with the study drug.
- Have previously been treated with ponatinib (or drugs of similar composition).
- Absorption disorder syndrome or other diseases affecting oral drug absorption.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HQP1351Orally, single dose of 30mg on day 1 and day 8. | Drug | A group, B group |
Primary outcome
Area under the curve from the time of dosing to infinity [AUC(0-inf)]
Time frame: 1-5 days after every drug administration
Area under the plasma concentration-time curve from time zero extrapolated to infinity time of HQP1351.
Area under the curve from the time of dosing to the last measurable concentration [AUC(0-last)]
Time frame: 1-5 days after every drug administration
Area under the plasma concentration-time curve from time zero to the last measurable time point of HQP1351.
Percentage of AUC(0-inf)_obs due to extrapolation from the last measurable time point to infinity (AUC_%Extrap)
Time frame: 1-5 days after every drug administration
Percentage of area under the concentration time curve from time zero extrapolated to infinite time obtained by extrapolation of HQP1351.
Maximum observed concentration (Cmax)
Time frame: 1-5 days after every drug administration
Maximum observed plasma concentration of HQP1351.
Time of maximum observed concentration (Tmax)
Time frame: 1-5 days after every drug administration
Time to maximum observed plasma concentration of HQP1351.
Terminal elimination half life (T1/2)
Time frame: 1-5 days after every drug administration
Terminal elimination half life (T1/2) is defined as the duration until observation of half of the maximum concentration of HQP1351.
Total body clearance for extravascular administration (CL/F)
Time frame: 1-5 days after every drug administration
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.
Volume of distribution based on the terminal phase for extravascular administration (Vz/F)
Time frame: 1-5 days after every drug administration
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 secondary outcome
Incidence of toxicity
Time frame: up to 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
QIAN JIANG, Professor principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HQP1351 in people with Chronic Myeloid Leukemia, Chronic Phase, run by Ascentage Pharma Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from the time of dosing to infinity [AUC(0-inf)] (time frame: 1-5 days after every drug administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.