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

Shire

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01824446

SPD602-109

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Radiolabeled SPD602

Experimental group

Treatment:

Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)