Clifutinib Food Effect Study in Healthy Subjects | NCT05454098

NCT05454098

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fed states in healthy subjects	Experimental	A single 40mg dose of Clifutinib administered in a fed state.	Drug: Clifutinib with fed state
Fasted states in healthy subjects	Experimental	A single 40mg dose of Clifutinib administered in a Fasted state.	Drug: Clifutinib with fasted state

Name	Type	Description	Arm Group Labels	Other Names
Clifutinib with fed state	Drug	40 mg Clifutinib with food	Fed states in healthy subjects

Outcomes Module

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

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

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
the First Hospital of Jilin University		Changchun	Jilin	130021	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41069609	Derived	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.