Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0914 · 1 trial · 1 indication
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...
AZD0914 is an investigational small molecule being developed by Innoviva, Inc. (INVA). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.
AZD0914 is being studied for use in healthy volunteers, as part of early clinical development. It is an investigational small molecule, and its specific therapeutic indication has not been established. The drug is not approved for any medical condition.
AZD0914 is being developed by Innoviva, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker INVA. The company is conducting clinical trials to evaluate the drug's properties in healthy subjects.
AZD0914 is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
AZD0914 has been studied in one completed Phase 1 clinical trial, NCT02298920, titled 'AZD0914 Phase 1 ADME Study in Healthy Volunteers.' This trial enrolled 6 healthy male participants in the United States and was not randomized or double-blinded.
No alternative names for AZD0914 have been reported. The drug is identified solely by its code name AZD0914 in clinical trial registries and development programs.