Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05101369 | A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550 | PHASE1 | COMPLETED | 7 | — | — | Jan 21, 2022 | Mar 25, 2022 | Aug 21, 2025 | 1 | United Kingdom |
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.
| 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...