Phase 1 N=6 Other

Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01807000 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate — 96.5 ng*h/ml

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Radiolabeled Prucalopride Succinate (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Shire
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate	96.5	—
PRIMARY Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate	3.79	—
PRIMARY Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate	2.75	—
PRIMARY Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate	20.6	—
PRIMARY Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate	20.9	—
PRIMARY Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate	623	—
PRIMARY AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate	192	—
PRIMARY Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate	7.74	—
PRIMARY Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate	2.75	—
PRIMARY Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate	18.0	—
PRIMARY AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate	102	—
PRIMARY Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate	4.14	—
PRIMARY Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate	2.25	—
PRIMARY Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate	19.7	—
PRIMARY Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate	84.2	—
PRIMARY Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate	13.3	—

Summary

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Eligibility Criteria

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

Exclusion Criteria

Have participated in a [14C]-study within the last 6 months.
Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
Male subjects who consume more than 21 units of alcohol per week or 3 units per day.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01807000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.