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NCT00879645 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function
A Phase 1 study, sponsored by Mallinckrodt.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00879645 is a Phase 1 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 28 participants.
The verdict
NCT00879645, a Phase 1 study, was terminated before completion, sponsored by Mallinckrodt.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DRUG Sodium Sulfide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00879645
The ClinicalTrials.gov registry entry for NCT00879645 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sodium Sulfide is the first listed.
NCT00879645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00879645 about?
NCT00879645 is a clinical study titled "Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function". 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 cohor...
What is the current status of trial NCT00879645?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2009-08. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00879645?
The interventions under investigation include: Sodium Sulfide (DRUG).
Who is sponsoring clinical trial NCT00879645?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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