Clifutinib Food Effect Study in Healthy Subjects

NCT ID: NCT05454098

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-08
• Study Completion Date: 2022-12-08

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.

Conditions

Acute Myeloid Leukemia in Children

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fed states in healthy subjects

A single 40mg dose of Clifutinib administered in a fed state.

Group Type: EXPERIMENTAL

Clifutinib with fed state

Intervention Type: DRUG

40 mg Clifutinib with food

Fasted states in healthy subjects

A single 40mg dose of Clifutinib administered in a Fasted state.

Group Type: EXPERIMENTAL

Clifutinib with fasted state

Intervention Type: DRUG

40 mg Clifutinib without food

Interventions

Clifutinib with fed state

40 mg Clifutinib with food

Intervention Type: DRUG

Clifutinib with fasted state

40 mg Clifutinib without food

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 41069609 (View on PubMed)

Other Identifiers

HEC73543-AML-103

Identifier Type: -

Identifier Source: org_study_id