Clifutinib Food Effect Study in Healthy Subjects

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia in Children
• Interventions: Drug: Clifutinib with fed state; Drug: Clifutinib with fasted state

• Registration Number: NCT05454098
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-11-08
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fed states in healthy subjects	Clifutinib with fed state	A single 40mg dose of Clifutinib administered in a fed state.
Fasted states in healthy subjects	Clifutinib with fasted state	A single 40mg dose of Clifutinib administered in a Fasted state.

Primary Outcome Measures

Name	Time	Method
AUC0-∞	4 weeks	Pharmacokinetics parameters in fasting state and fed state
Cmax	4 weeks	Pharmacokinetics parameters in fasting state and fed state

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Through study completion, an average of 4 weeks	Safety and tolerability measure by number of subjects who experience adverse events

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China