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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02298920 | AZD0914 Phase 1 ADME Study in Healthy Volunteers | PHASE1 | COMPLETED | 6 | — | — | Jan 1, 2015 | Feb 1, 2015 | Jun 3, 2015 | 2 | United States |
Maximum observed concentration (Cmax), time to maximum observed concentration (tmax), area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-t), area under the concentration-time curve extrapolated to infinity (AUC0-inf), apparent terminal elimination rate constant (lambdaZ), apparent terminal elimination half-life (t1/2), apparent clearance (Cl/F) (oral and AZD0914 only), and apparent volume of distribution (Vz/F) (AZD0914 only). Ratios for area under the concentration-time curve extrapolated to infinity including the ratio of total radioactivity in whole blood/plasma and the ratio of non-radiolabeled AZD0914 in plasma/total radioactivity in plasma, will be calculated as appropriate.
The following pharmacokinetic parameters will be calculated, whenever possible, based on the urine total radioactivity concentrations: amount excreted in urine (Aeu) over the sampling interval, renal clearance (CLR), and the percent excreted in urine (%Feu). For fecal total radioactivity concentrations, the following pharmacokinetic parameters will be calculated for \[14C\] AZD0914 derived radioactivity: amount excreted in feces (Aef) over the sampling interval and the percent excreted in feces (%Fef).
Metabolites of \[14C\]-AZD0914 will be identified. Pharmacokinetic parameters for the metabolites of \[14C\]-AZD0914 will be calculated, as deemed appropriate, based on plasma and urine concentration levels. Data may be presented in a separate report.
| Arm | Type | Description |
|---|---|---|
| Single Group | EXPERIMENTAL | Open Label ADME Study |
| Name | Type | Description |
|---|---|---|
| AZD0914 | DRUG | Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers. |
Inclusion Criteria: 1. Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture; 2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements; 3. With...