This trial is completed!
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You can access this
clinical trial
if you have
Hepatic Impairment or Healthy
and you are
between 18 and 65
years old
Phase
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

The purpose of this study is to evaluate how much of the study drug SSP-004184 (SPD602) is absorbed by the body and how long it takes to be eliminated from the body in healthy subjects and subjects with mild, moderate, and severe hepatic (liver) impairment compared with subjects with healthy normal liver function.

Provided treatments

  • Drug: SSP-004184
Tris trial is registered with FDA with number: NCT01732263. The sponsor of the trial is Shire and it is looking for 44 volunteers for the current phase.
Official trial title:
A Phase 1, Open-label, Single-dose Study of the Pharmacokinetics, Safety, and Tolerability of SSP-004184 (SPD602) in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects