Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tozadenant · 1 trial · 1 indication
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...
Tozadenant is an investigational small molecule being developed by Tandem Diabetes Care, Inc. (TNDM). It is currently in Phase 1 clinical development. As of the available data, it has been studied in healthy volunteers, and its specific therapeutic indication has not been established.
Tozadenant is being developed by Tandem Diabetes Care, Inc., a company traded under the ticker symbol TNDM. The drug is currently in Phase 1 clinical development.
Tozadenant is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities.
Tozadenant has been studied in one completed Phase 1 clinical trial, identified as NCT02240290. This trial evaluated the absorption, distribution, breakdown, elimination, and safety of 14C-labeled tozadenant in healthy male volunteers in the Netherlands.
Tozadenant is not known to have any alternative names. It is a distinct investigational small molecule being developed by Tandem Diabetes Care, Inc.