Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Radiolabeled SPD557 · 1 trial · 1 indication
Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
| Arm | Type | Description |
|---|---|---|
| Radiolabeled SPD557 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Radiolabeled SPD557 | DRUG | A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1 |
Key Inclusion Criteria: * Males ages 18 to 50 years * Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2 * Subject is willing to comply with any applicable contraceptive and sperm donation requirements Key Exclusion criteria: * Have participated in a \[14C\]-study within the last 6 months. * Exp...
Radiolabeled SPD557 is an investigational small molecule being studied in healthy volunteers. It is a radiolabeled form of the drug SPD557, used in an absorption, metabolism and excretion (AME) study to track how the compound is processed in the body. It is not approved for any medical condition.
Radiolabeled SPD557 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company sponsored a Phase 1 clinical trial to evaluate the drug's absorption, metabolism and excretion in healthy male volunteers.
Radiolabeled SPD557 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is no longer in active clinical testing.
Radiolabeled SPD557 has one completed clinical trial, NCT01786876, titled "Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers." This Phase 1 study enrolled 6 healthy male participants in the United States and was not randomized or blinded.
Radiolabeled SPD557 is a radiolabeled version of the drug SPD557, meaning it contains a radioactive isotope to allow tracking in the body. It is used specifically in the AME study to understand how SPD557 is absorbed, metabolized and excreted. The radiolabeled form is not a separate therapeutic drug.