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Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function

NCT00879645 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-12-17

Study results available
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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.

Conditions

  • Renal Impairment

Interventions

DRUG

Sodium Sulfide

Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours

DRUG

Sodium Sulfide

Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours

DRUG

Sodium Sulfide

Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours

DRUG

Sodium Sulfide

Sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Brahm Goldstein, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879645 on ClinicalTrials.gov