NCT01824446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 12, 2014

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

28 days

First QC Date

April 1, 2013

Results QC Date

April 11, 2014

Last Update Submit

June 22, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (20)

  • 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.

Study Arms (1)

Radiolabeled SPD602

EXPERIMENTAL
Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)

Interventions

Radiolabeled SPD602 (FBS0701, SSP-004184)DRUG

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

Also known as: SPD602
Radiolabeled SPD602

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

4,5-dihydro-2-(2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl)-4-methyl-4-thiazolecarboxylic acid

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 4, 2013

Study Start

May 1, 2013

Primary Completion

May 29, 2013

Study Completion

May 29, 2013

Last Updated

June 24, 2021

Results First Posted

May 12, 2014

Record last verified: 2021-06

Locations

US(1)