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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03931590 | A Human AME Study for Omaveloxolone | PHASE1 | COMPLETED | 8 | — | — | Apr 11, 2019 | May 31, 2019 | May 30, 2025 | 1 | United States |
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity
Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.
Rates and routes of elimination will be assessed by urine sampling for radioactivity.
Rates and routes of elimination will be assessed by sampling of feces for radioactivity.
| Arm | Type | Description |
|---|---|---|
| Healthy Male Subjects | EXPERIMENTAL | Single oral dose of 150 mg of \[14C\] omaveloxolone containing approximately 90 μCi as a capsule after an overnight fast of at least 10 hours. |
| Name | Type | Description |
|---|---|---|
| [14C]-Omaveloxolone | DRUG | \[14C\]-Omaveloxolone 50 mg capsules |
Inclusion Criteria: * Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated: * Males, of any race, between 18 and 55 years of age, inclusive. * Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and a total body weight \> 50 kg. * Be surgicall...