Clifutinib Food Effect Study in Healthy Subjects

NCT05454098 | Completed Phase 1

• 1 other identifier: HEC73543-AML-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cmax

  Pharmacokinetics parameters in fasting state and fed state

  4 weeks

• AUC0-∞

  Pharmacokinetics parameters in fasting state and fed state

  4 weeks

Secondary Outcomes (1)

• Adverse Events

  Through study completion, an average of 4 weeks

Study Arms (2)

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

Interventions

Clifutinib with fed state DRUG

40 mg Clifutinib with food

Fed states in healthy subjects

Clifutinib with fasted state DRUG

40 mg Clifutinib without food

Fasted states in healthy subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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.

  PMID: 41069609 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: November 8, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: March 21, 2023

Record last verified: 2022-07

Locations

CN (1)