NCT01732263

Study of SSP-004184 (SPD602) in Healthy Adults and Subjects With Impaired Liver Function

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	SSP-004184	All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1

Timeline

• Start date: 2012-11-09
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-11-22
• Last updated: 2021-07-19
• Results posted: 2014-05-15

Locations

2 sites across 1 country: United States