Recent Updates
Recently added Catalysts

Clifutinib with

Phase 1

Acute Myeloid Leukemia in Children | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Mar 21, 2023

Target and mechanism

ModalitySmall molecule

Also known as Clifutinib with fed state

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Clifutinib with · 1 trial · 1 indication

Phase 1 1
NCT05454098Clifutinib Food Effect Study in Healthy SubjectsAcute Myeloid Leukemia in Children
COMPLETED40 Analytics
PHASE1COMPLETED
Clifutinib Food Effect Study in Healthy Subjects
Acute Myeloid Leukemia in ChildrenUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
4 weeks

Pharmacokinetics parameters in fasting state and fed state

AUC0-∞
4 weeks

Pharmacokinetics parameters in fasting state and fed state

Secondary Endpoints

Adverse Events
Through study completion, an average of 4 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Fed states in healthy subjectsEXPERIMENTALA single 40mg dose of Clifutinib administered in a fed state.
Fasted states in healthy subjectsEXPERIMENTALA single 40mg dose of Clifutinib administered in a Fasted state.

Interventions

NameTypeDescription
Clifutinib with fed stateDRUG40 mg Clifutinib with food
Clifutinib with fasted stateDRUG40 mg Clifutinib without food
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:China
Unlock Eligibility Criteria