Clifutinib Food Effect Study in Healthy Subjects

Acute Myeloid Leukemia in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05454098
• Other study ID #: HEC73543-AML-103
• Status: Completed
• Phase: Phase 1
• Start date: November 8, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: July 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia in Children

Intervention

Drug:
• Clifutinib with fed state
40 mg Clifutinib with food
• Clifutinib with fasted state
40 mg Clifutinib without food

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Pharmacokinetics parameters in fasting state and fed state	4 weeks
Primary	AUC0-8	Pharmacokinetics parameters in fasting state and fed state	4 weeks
Secondary	Adverse Events	Safety and tolerability measure by number of subjects who experience adverse events	Through study completion, an average of 4 weeks