Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Radiolabeled SPD602 · 1 trial · 1 indication
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 administrated.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
The time it takes for the blood plasma concentration of a substance to halve.
The rate at which a drug is removed from the body.
The distribution of a medication between plasma and the rest of the body.
| Arm | Type | Description |
|---|---|---|
| Radiolabeled SPD602 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Radiolabeled SPD602 (FBS0701, SSP-004184) | DRUG | A single oral dose of 3g of radio-labelled SSP-004184 on Day 1 |
Inclusion Criteria: * Healthy adult male subjects aged between 18 and 65 years inclusive Exclusion Criteria: \-
Radiolabeled SPD602 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It is a radiolabeled version of the compound, designed for use in a Phase 1 absorption, metabolism, and excretion study. The drug is not approved and remains in clinical development.
Radiolabeled SPD602 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this investigational asset.
Radiolabeled SPD602 is in Phase 1 clinical development. The only recorded trial for this drug is a completed Phase 1 study. It is investigational and has not been approved by the FDA or any regulatory agency.
Radiolabeled SPD602 has been studied in one completed Phase 1 trial, NCT01824446, titled "AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184." The trial enrolled 6 healthy male volunteers in the United States and was an uncontrolled, non-randomized study.
Yes, Radiolabeled SPD602 is also known as FBS0701 and SSP-004184. These alternative names refer to the same investigational compound. The trial NCT01824446 used the name Radiolabeled SSP-004184.