Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clifutinib · 1 trial · 1 indication
Pharmacokinetics parameters in fasting state and fed state
Pharmacokinetics parameters in fasting state and fed state
| Arm | Type | Description |
|---|---|---|
| Fed states in healthy subjects | EXPERIMENTAL | A single 40mg dose of Clifutinib administered in a fed state. |
| Fasted states in healthy subjects | EXPERIMENTAL | A single 40mg dose of Clifutinib administered in a Fasted state. |
| Name | Type | Description |
|---|---|---|
| Clifutinib with fed state | DRUG | 40 mg Clifutinib with food |
| Clifutinib with fasted state | DRUG | 40 mg Clifutinib without food |
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 ...
Clifutinib with fed state refers to the administration of the kinase inhibitor clifutinib under fed conditions, meaning after food intake. It is also known as Clifutinib with fed state. This designation distinguishes it from fasting administration in clinical studies. The drug is being developed by Sunshine Biopharma Inc. (SBFM) for acute myeloid leukemia in children.
Clifutinib with fed state is being studied for the treatment of acute myeloid leukemia in children. It is an investigational small molecule kinase inhibitor. The fed state refers to dosing after food, which can affect how the drug is absorbed. It has not been approved for any indication.
Clifutinib with fed state targets kinases, as it belongs to the -tinib class of small molecule kinase inhibitors. Kinases are enzymes that regulate cell signaling pathways involved in cancer growth. By inhibiting specific kinases, clifutinib may interfere with processes that drive acute myeloid leukemia in children.
Clifutinib with fed state is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is responsible for the clinical development of this kinase inhibitor for pediatric acute myeloid leukemia.
Clifutinib with fed state is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The Phase 1 program includes a completed food effect study in healthy subjects.
Clifutinib with fed state has been evaluated in a Phase 1 trial, NCT05454098, titled Clifutinib Food Effect Study in Healthy Subjects. This completed trial enrolled 40 healthy adult volunteers in China to assess the effect of food on the drug. No active trials are currently listed.