Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Larotinib · 3 trials · 4 indications
Maximum plasma concentration of study drugs
AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity, calculated using the observed value of the last quantifiable concentration for Larotinib
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Proportion of different metabolites(Larotinib and main metabolites） .
| Arm | Type | Description |
|---|---|---|
| Cohort A-Larotinib | EXPERIMENTAL | Cohort A:Healthy participants with normal hepatic function （match to subjects with mild hepatic impairment\_cohort B） |
| Cohort B-Larotinib | EXPERIMENTAL | Subjects with mild hepatic impairment |
| Cohort C-Larotinib | EXPERIMENTAL | Healthy participants with normal hepatic function （match to subjects with moderate hepatic impairment\_cohort D） |
| Cohort D-Larotinib | EXPERIMENTAL | Subjects with moderate hepatic impairment. |
| Part A, Treatment Sequence(Larotinib-Larotinib/Rifampin) | EXPERIMENTAL | Larotinib , capsules (150mg\*2+50mg\*1), at Hour 0 on Day 1 followed by an overnight fast. On Days 15 to 26, participants received rifampin 600 mg as capsules, orally, once daily (QD) and Larotinib 350 mg as capsules, orally was coadministered on Day 20. There was a washout period of 13 days between the two treatments. |
| Part B, Treatment Sequence(Larotinib-Larotinib/itraconazole) | EXPERIMENTAL | Larotinib , capsules (150mg\*2+50mg\*1), at Hour 0 on Day 1 followed by an overnight fast. On Days 15 to Day 25, participants received itraconazole 200 mg solution, orally, once daily (QD) on Days 15 to Day 25 and a single oral dose of Larotinib 350 mg as capsule was coadministered on Day 19 (Treatment B). There was a washout period of 13 days between the two treatments. |
| [14C]-Larotinib | EXPERIMENTAL | Patients will receive single dose of \[14C\]-Larotinib (Suspension, 350mg/100μCi). |
| Name | Type | Description |
|---|---|---|
| Larotinib | DRUG | Capsules, Oral, 350 mg, single dose, one day |
| Rifampin | DRUG | Rifampin Capsules |
| Itraconazole | DRUG | Itraconazole Capsules |
| [14C]-Larotinib | DRUG | Patients will receive single dose of orally \[14C\]-Larotinib on Day 1. |
Inclusion Criteria: * healthy subjects with normal hepatic function (cohorts A and C) : * 1\. Sign the informed consent form before the trial； * 2\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg/m\^...
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Larotinib is an investigational small molecule kinase inhibitor being developed for oncology. It is being studied in clinical trials for esophageal cancer and advanced solid tumors, as well as in healthy volunteers for pharmacokinetic studies. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Larotinib is a kinase inhibitor, as indicated by its '-tinib' suffix, which denotes a tyrosine kinase inhibitor class. It is designed to target kinases involved in cancer cell growth and proliferation. However, the specific molecular target has not been disclosed in the available clinical trial information.
Larotinib is being developed by Sunshine Biopharma Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol SBFM. The drug is currently in Phase 1 clinical trials, with studies being conducted in China.
Larotinib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. All three of its registered clinical trials are Phase 1 studies, which are designed to evaluate the drug's safety, tolerability, and pharmacokinetics in humans.
Larotinib has three Phase 1 clinical trials registered. NCT05048368 is a pharmacokinetics study in subjects with impaired hepatic function, enrolling 32 participants with esophageal cancer or advanced solid tumors. NCT05057949 is a completed drug-drug interaction study with itraconazole and rifampin in 32 healthy volunteers. NCT05059743 is a completed ADME study of [14C]-Larotinib in 6 healthy male subjects.
Larotinib is the primary name used for this investigational drug in clinical trial registrations. No alternative names or aliases have been listed in the available clinical trial information. It is consistently referred to as Larotinib across all registered studies.