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Completed

NCT Number: NCT01824446

AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184

To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance 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

  • Healthy adult male subjects aged between 18 and 65 years inclusive

Exclusion criteria

-

Treatment and study plan

Radiolabeled SPD602 (FBS0701, SSP-004184)

Drug

A single oral dose of 3g of radio-labelled SSP-004184 on Day 1

Other names: SPD602

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

    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-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

  3. Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

    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 SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

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

  5. Total Body Clearance (CL/F) of Radio-Labelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

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

  6. Volume of Distribution (Vz/F) of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

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

  7. AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  8. Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  9. Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  10. Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  11. CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  12. Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  13. AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  14. Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  15. Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  16. Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  17. CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  18. Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  19. Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

  20. Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184

    Time frame: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.

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]SSP-004184 Following a Single Oral Dose in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Jun 24, 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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