Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Radiolabeled Prucalopride · 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 administered.
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 Prucalopride Succinate | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Radiolabeled Prucalopride Succinate | DRUG | A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1. |
Inclusion Criteria: * Males aged between 18 and 50 years, inclusive * Body mass index (BMI) of ≥18 and ≤30 kg/m2 * No more than 2 bowel movements per day or fewer than 3 bowel movement per week * Provision of signed and dated, written informed consent prior to any study specific procedures Exclusi...
Radiolabeled Prucalopride is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited (TAK). It is a radiolabeled form of prucalopride succinate, studied in healthy volunteers to assess its absorption, metabolism, and excretion. It is currently in Phase 1 clinical development.
Radiolabeled Prucalopride is used for research purposes in healthy volunteers. It is being studied to understand the absorption, metabolism, and excretion of a single dose of the drug. It is not intended for therapeutic use in any disease condition.
Radiolabeled Prucalopride is developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker symbol TAK. The company is conducting clinical research on this investigational drug.
Radiolabeled Prucalopride is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, and the drug is not currently in active clinical trials.
Radiolabeled Prucalopride has one completed clinical trial, NCT01807000, titled "Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers." This Phase 1 study enrolled 6 healthy male volunteers in the United States.
Radiolabeled Prucalopride is a radiolabeled form of prucalopride succinate, meaning it contains a radioactive label for research purposes. It is used in clinical studies to track the drug's absorption, metabolism, and excretion in the body.