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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02240290 | Study to Evaluate the Absorption, Distribution, Break Down and Elimination and the Safety of 14C-Labeled Tozadenant | PHASE1 | COMPLETED | 6 | — | — | Sep 1, 2013 | Oct 1, 2013 | Aug 4, 2017 | 1 | Netherlands |
Time evolution of radioactivity in plasma, blood, urine, feces and expired air from pre-dose to day 14. Cumulative time evolution of percentage of radioactivity in urine, feces, expired air and total. Total mass balance in percentage of dose. This outcome measure is a composite outcome. This means that multiple measurements will be reflected as one value for each study arm.
Pharmacokinetics parameters computed on radioactivity concentrations: Plasma and blood: Cmax, tmax, AUC(0-t), apparent t1/2, AUC, elimination constant (λz) Cumulative amount excreted in urine, feces, and expired air This outcome measure is a composite outcome. This means that multiple measurements will be reflected as one value for each study arm.
| Arm | Type | Description |
|---|---|---|
| tozadenant | EXPERIMENTAL | A single dose of 240 mg tozadenant (four 60 mg tablets) and a 74 kBq (2 μCi) 14C-labeled tozadenant capsule will be administered with 240 mL of water. |
| Name | Type | Description |
|---|---|---|
| tozadenant tablet | DRUG | Active substance: tozadenant Pharmaceutical form: Tablet Concentration: 240 mg Route of Administration: Oral administration |
| C14-tozadenant capsule | DRUG | Active substance: C14-tozadenant Pharmaceutical form: Capsule Concentration: 74 kBq (2 μCi) Route of administration: Oral administration |
Inclusion Criteria: * Subject is a male between the ages of 18 and 55 years inclusive; subject may be of any racial group * Subject is informed and given ample time and opportunity to think about his participation and has signed and dated the Independent Ethics Committee (IEC) approved written Info...