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 developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial involving healthy adult male volunteers in the United States. The compound is a radiolabeled version of SPD557, used to study how the drug is absorbed, metabolized, and excreted in the body.
Radiolabeled SPD557 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical research conducted on this investigational compound.
Radiolabeled SPD557 is in Phase 1 clinical development. It is an investigational compound and has not been approved by the FDA. The single Phase 1 trial of Radiolabeled SPD557 has been completed.
Radiolabeled SPD557 has been studied in one Phase 1 clinical trial, NCT01786876, titled "Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers." The trial enrolled 6 healthy male volunteers in the United States and is now completed.
NCT01786876 was a completed Phase 1 trial of Radiolabeled SPD557 in healthy volunteers. It was an uncontrolled, open-label study with 6 male participants aged 18 years and older, conducted in the United States. The trial examined the adsorption, metabolism, and excretion of a single radiolabeled dose of SPD557.