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 drug being developed by Innoviva, Inc. (ticker INVA). It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific therapeutic indication for AZD0914 has not been disclosed.
AZD0914 is being developed by Innoviva, Inc., which trades on the Nasdaq under the ticker symbol INVA. Innoviva is the company responsible for the clinical development of this investigational small molecule.
AZD0914 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently listed as active in any ongoing trials. As a Phase 1 investigational drug, it has not been approved by the FDA for any indication.
AZD0914 has been evaluated in one completed Phase 1 trial, NCT02298920, titled 'AZD0914 Phase 1 ADME Study in Healthy Volunteers.' The trial enrolled 6 healthy male volunteers in the United States and was an uncontrolled study.