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Completed

NCT Number: NCT01807000

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Global Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiolabeled Prucalopride Succinate

Drug

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

Primary outcomes

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

    Time frame: Over 240 hours post-dose

    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.

  2. Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

    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.

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

    Time frame: Over 240 hours post-dose

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

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

    Time frame: Over 240 hours post-dose

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

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

    Time frame: Over 240 hours post-dose

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

  6. Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

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

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

    Time frame: Over 240 hours post-dose

  8. Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  9. Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  10. Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  11. AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  12. Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  13. Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  14. Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

  15. Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate

    Time frame: 240 hours post-dose

  16. Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate

    Time frame: Over 240 hours post-dose

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2013
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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