Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Radiolabeled Prucalopride Succinate
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 a small molecule drug candidate developed by Takeda Pharmaceutical Company Limited. It is a radiolabeled version of prucalopride succinate, used in a Phase 1 clinical trial to study how the drug is absorbed, metabolized, and excreted in the body. The trial was conducted in healthy male volunteers.
Radiolabeled Prucalopride is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. Takeda is a global pharmaceutical company. The drug is currently in Phase 1 clinical development.
Radiolabeled Prucalopride is in Phase 1 clinical development. One Phase 1 trial has been completed. There are no active trials at this time. The drug has not been approved by the FDA and remains investigational.
Radiolabeled Prucalopride has been studied in one completed Phase 1 clinical trial, NCT01807000, titled "Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers." The trial enrolled 6 healthy male volunteers in the United States and was completed.
Yes, Radiolabeled Prucalopride is also known as Radiolabeled Prucalopride Succinate. The succinate form is the specific salt used in the clinical trial. Both names refer to the same investigational drug candidate developed by Takeda Pharmaceutical Company Limited.