At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 44 enrolled
Drug / intervention
SSP-004184drug
Likely dose
SSP-004184 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating SSP-004184 for Hepatic Impairment and Healthy. Completed, enrolled 44 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment, Healthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionApr 2013
TodayJul 2026
First PostedNov 22, 2012
Enrollment StartNov 9, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.6 years ago
Interventions
SSP-004184drug
All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1