Clinical trial NCT01807000: Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers
Official title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Prucalopride Succinate Following a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-03-08
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
measure: Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate
timeFrame: 240 hours post-dose
measure: Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate
timeFrame: Over 240 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Global Clinical Research Unit Inc.
state: Wisconsin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Flach S, Scarfe G, Dragone J, Ding J, Seymour M, Pennick M, Pankratz T, Troy S, Getsy J. A Phase I Study to Investigate the Absorption, Pharmacokinetics, and Excretion of [(14)C]Prucalopride After a Single Oral Dose in Healthy Volunteers. Clin Ther. 2016 Sep;38(9):2106-15. doi: 10.1016/j.clinthera.2016.08.003. Epub 2016 Sep 7.