At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
IDN-6556drug
Likely dose
Not stated in 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.
An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Severe Renal Impairment and in Matched Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating IDN-6556 for Renal Impairment and 3 related conditions. Completed, enrolled 16 participants across 2 sites.
Detailed Summary
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers with normal renal function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment, Renal Insufficiency, Kidney Disease, Kidney Diseases
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionApr 2014
TodayJul 2026
First PostedJan 20, 2014
Enrollment StartJan 1, 2014
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.5 years ago
Interventions
IDN-6556drug