Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01807000 | Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers | PHASE1 | COMPLETED | 6 | — | — | Mar 18, 2013 | Apr 28, 2013 | Jun 10, 2021 | 1 | United States |
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...