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

NCT01807000 | Completed Phase 1 Results

• 1 other identifier: SPD555-104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (16)

• Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate

  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.

  Over 240 hours post-dose

• Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate

  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.

  Over 240 hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate

  Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.

  Over 240 hours post-dose

• Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate

  The time it takes for the blood plasma concentration of a substance to halve.

  Over 240 hours post-dose

• Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate

  The rate at which a drug is removed from the body.

  Over 240 hours post-dose

• Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate

  The distribution of a medication between plasma and the rest of the body.

  Over 240 hours post-dose

• AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

• Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate

  240 hours post-dose

• Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate

  Over 240 hours post-dose

Study Arms (1)

Radiolabeled Prucalopride Succinate

EXPERIMENTAL

Drug: Radiolabeled Prucalopride Succinate

Interventions

Radiolabeled Prucalopride Succinate DRUG

A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.

Radiolabeled Prucalopride Succinate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Covance Global Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• 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.

  PMID: 27614912 DERIVED

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: March 18, 2013
• Primary Completion: April 28, 2013
• Study Completion: April 28, 2013
• Last Updated: June 10, 2021
• Results First Posted: September 5, 2014

Record last verified: 2021-05

Locations

US (1)