Acute Myeloid Leukemia in ChildrenPhase 1NCT05454098
Clifutinib Food Effect Study in Healthy Subjects
A Phase 1 study testing Clifutinib with fed state and Clifutinib with fasted state in people with Acute Myeloid Leukemia in Children, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia in Children
- What is being tested?
- Clifutinib with fed state and Clifutinib with fasted state
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2022to 8 Dec 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects (male or female), age greater than or equal to 18 years and less than or equal to 45 years;
- Weight ≥50 kg (≥45 kg for female), and have a body mass index (BMI) between 18 and 28 (including 18 and 28) at screening;
- Physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator;
- Male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose, and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating；
- Volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures.
Who cannot join
- Have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
- Unable to tolerate standard meals;
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 ms (female >480 ms), or history of long QT syndrome；
- Have received live vaccine(s) within 3 months prior to screening;
- Have used over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study;
- Have known allergy to any drug or food;
Show all 9Show fewer
- Smoking more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) within 3 months prior to screening, or unwilling to abide by smoking restrictions during the study;
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody ,human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody;
- Known history of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Food Effect Phase I Study of the Clifutinib in Healthy Subjects
The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.
- Conditions
- Acute Myeloid Leukemia in Children
- Being tested
- Clifutinib with fed state, Clifutinib with fasted state
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clifutinib with fed stateDrug
40 mg Clifutinib with food
Clifutinib with fasted stateDrug
40 mg Clifutinib without food
| Study group | Role | What they receive |
|---|---|---|
| Fed states in healthy subjects | Experimental | A single 40mg dose of Clifutinib administered in a fed state. Receives: Drug: Clifutinib with fed state |
| Fasted states in healthy subjects | Experimental | A single 40mg dose of Clifutinib administered in a Fasted state. Receives: Drug: Clifutinib with fasted state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics parameters in fasting state and fed state
Measured: 4 weeks
AUC0-∞
Pharmacokinetics parameters in fasting state and fed state
Measured: 4 weeks
Secondary outcomes (1)
Adverse Events
Safety and tolerability measure by number of subjects who experience adverse events
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start8 Nov 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia in ChildrenStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454098
- Sponsor's protocol ID
- HEC73543-AML-103
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang D, Wu M, Li X, Jiang Y, Liu B, Zhang Y, Deng L, Ding Y. A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharmacokinetics after oral dosing in healthy Chinese volunteers. Front Pharmacol. 2025 Oct 8;16:1636504. doi: 10.3389/fphar.2025.1636504. eCollection 2025.
PubMed 41069609
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Food Effect Phase I Study of the Clifutinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05454098
- Acronym / sponsor ID
- HEC73543-AML-103
- Conditions
- Acute Myeloid Leukemia in Children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 12 Jul 2022 (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 evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fed states in healthy subjects | Experimental | Drug: Clifutinib with fed stateA single 40mg dose of Clifutinib administered in a fed state. |
| Fasted states in healthy subjects | Experimental | Drug: Clifutinib with fasted stateA single 40mg dose of Clifutinib administered in a Fasted state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects (male or female), age greater than or equal to 18 years and less than or equal to 45 years;
- Weight ≥50 kg (≥45 kg for female), and have a body mass index (BMI) between 18 and 28 (including 18 and 28) at screening;
- Physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator;
- Male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose, and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating；
- Volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures.
Key exclusion criteria (9 listed)
- Have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs;
- Unable to tolerate standard meals;
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 ms (female >480 ms), or history of long QT syndrome；
- Have received live vaccine(s) within 3 months prior to screening;
- Have used over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study;
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 |
|---|---|---|
| Clifutinib with fed state40 mg Clifutinib with food | Drug | Fed states in healthy subjects |
| Clifutinib with fasted state40 mg Clifutinib without food | Drug | Fasted states in healthy subjects |
Primary outcome
Cmax
Time frame: 4 weeks
Pharmacokinetics parameters in fasting state and fed state
AUC0-∞
Time frame: 4 weeks
Pharmacokinetics parameters in fasting state and fed state
1 secondary outcome
Adverse Events
Time frame: Through study completion, an average of 4 weeks
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 21 Mar 2023.
- Derived from this study: PubMed 41069609Wang D, Wu M, Li X, Jiang Y, Liu B, Zhang Y, Deng L, Ding Y. A phase I study of HEC73543, an oral FLT3 inhibitor: the effect of food on pharmacokinetics after oral dosing in healthy Chinese volunteers. Front Pharmacol. 2025 Oct 8;16:1636504. doi: 10.3389/fphar.2025.1636504. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clifutinib with fed state and Clifutinib with fasted state in people with Acute Myeloid Leukemia in Children, run by Sunshine Lake Pharma Co., Ltd. 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 5 inclusion and 9 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 21 Mar 2023. 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?
Cmax (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454098, which also lists 1 linked publication.
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 21 Mar 2023.