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

NCT ID: NCT01824446

Last Updated: 2021-06-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2013-05-29

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Radiolabeled SPD602

Group Type EXPERIMENTAL

Radiolabeled SPD602 (FBS0701, SSP-004184)

Intervention Type DRUG

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

Interventions

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Radiolabeled SPD602 (FBS0701, SSP-004184)

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

Intervention Type DRUG

Other Intervention Names

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SPD602

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Covance Clinical Research Unit Inc

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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SPD602-109

Identifier Type: -

Identifier Source: org_study_id

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