Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function

Summary

This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in healthy volunteers as well as in subjects with varying degrees of impaired renal function. A total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4 cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth cohort will be subjects with intermediate renal impairment and the third cohort will be subjects with severe renal impairment and the second cohort will consist of normal healthy subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV) infusion and will be followed over a 7 day period.

Timeline

Start

2009-08

Primary completion

2010-03

Completion

2010-03

Outcome

Outcome not reported

Stopped: “unable to develop a rapid \& reliable assay to detect sulfide concentrations”

Drugs

Indications