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

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]SSP-004184 Following a Single Oral Dose in Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: SPD602

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184	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.	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.
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184	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.	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.
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184	Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.	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.
Plasma Half-Life (T1/2) of Radiolabelled SSP-004184	The time it takes for the blood plasma concentration of a substance to halve.	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.
Total Body Clearance (CL/F) of Radio-Labelled SSP-004184	The rate at which a drug is removed from the body.	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.
Volume of Distribution (Vz/F) of Radiolabelled SSP-004184	The distribution of a medication between plasma and the rest of the body.	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 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184		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 Whole Blood Total Radioactivity of Radiolabelled SSP-004184		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 Whole Blood Total Radioactivity of Radiolabelled SSP-004184		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.
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184		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.
CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184		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.
Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184		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 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184		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 Plasma Total Radioactivity of Radiolabelled SSP-004184		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 Plasma Total Radioactivity of Radiolabelled SSP-004184		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.
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184		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.
CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184		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.
Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184		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.
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184		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.
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184		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.

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): May 29, 2013
• Study Completion (Actual): May 29, 2013

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SPD602-109