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INCB086550 · 2 trials · 2 indications
To determine the route of elimination and mass balance of \[14C\]-INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) \[14C\]-INCB086550.
To characterize the metabolic profile and identify circulating and excreted metabolites of INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) \[14C\]-INCB086550 using liquid chromatography with mass spectral detection.
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
| Arm | Type | Description |
|---|---|---|
| INCB086550 | EXPERIMENTAL | Participants will be administered INCB086550 orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. |
| Name | Type | Description |
|---|---|---|
| INCB086550 | DRUG | INCB086550 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Male healthy adult participants aged 35 to 55 years, inclusive, at the time of screening. * Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening. * No clinically significan...
INCB086550 is an investigational small molecule being studied for the treatment of advanced solid tumors. It has been evaluated in clinical trials involving participants with solid tumors, as well as in healthy volunteers for pharmacokinetic studies. The drug is still in clinical development and is not approved.
INCB086550 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. Incyte is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of this investigational drug.
INCB086550 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in participants with advanced solid tumors and another in healthy volunteers. The drug remains investigational and has not been approved by regulatory authorities.
INCB086550 has been studied in two completed Phase 1 trials. NCT03762447 evaluated the drug in 138 participants with advanced solid tumors across the United States, Belgium, France, Italy, and the United Kingdom. NCT05101369 assessed mass balance and pharmacokinetics in 7 healthy male volunteers in the United Kingdom.
No, INCB086550 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials, but it has not received approval from the FDA or any other regulatory agency. The drug is still in clinical development and its safety and efficacy have not been established.