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

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ClinicalTrials.gov Identifier: NCT01824446
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : May 12, 2014
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Radiolabeled SPD602 (FBS0701, SSP-004184) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : May 29, 2013
Actual Study Completion Date : May 29, 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiolabeled SPD602 Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Other Name: SPD602


Outcome Measures
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Primary Outcome Measures :
  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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824446


Locations
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United States, Wisconsin
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01824446    
Other Study ID Numbers: SPD602-109
First Posted: April 4, 2013    Key Record Dates
Results First Posted: May 12, 2014
Last Update Posted: June 24, 2021
Last Verified: June 2021