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Completed

NCT Number: NCT01786876

Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 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] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 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 Volunteers

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Males ages 18 to 50 years
  • Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2
  • Subject is willing to comply with any applicable contraceptive and sperm donation requirements

Key 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.
  • Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days

Treatment and study plan

Radiolabeled SPD557

Drug

A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

    Area under the plasma concentration versus time curve from time 0 to infinity. 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 SSP-002358

    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 SSP-002358

    Time frame: Over 240 hours post-dose

  4. Plasma Half-Life (T1/2) of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  5. AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  6. Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  7. Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  8. Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  9. AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  10. Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  11. Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  12. Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  13. Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358

    Time frame: Over 240 hours post-dose

  14. Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358

    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]SPD557 Following a Single Oral Dose in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 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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