Clifutinib Food Effect Study in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Food Effect Phase I Study of the Clifutinib in Healthy Subjects

Conditions
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Acute Myeloid Leukemia in Children

Intervention / Treatment
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* Drug: Clifutinib with fed state
* Drug: Clifutinib with fasted state


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fed states in healthy subjects<br>A single 40mg dose of Clifutinib administered in a fed state. | Drug: Clifutinib with fed state<br>* 40 mg Clifutinib with food<br>|
| Experimental: Fasted states in healthy subjects<br>A single 40mg dose of Clifutinib administered in a Fasted state. | Drug: Clifutinib with fasted state<br>* 40 mg Clifutinib without food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetics parameters in fasting state and fed state | 4 weeks | 
| AUC0-∞ | Pharmacokinetics parameters in fasting state and fed state | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Safety and tolerability measure by number of subjects who experience adverse events | Through study completion, an average of 4 weeks |