Clifutinib Food Effect Study in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia in Children
• Intervention / Treatment: Drug: Clifutinib with fed state; Drug: Clifutinib with fasted state

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HEC73543-AML-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No