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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: Clinical Trial Phase 1 study, sponsored by Mallinckrodt.
NCT00879645 is a Phase 1 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.
Interventions
- DRUG Sodium Sulfide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
Why NCT00879645 stopped before completion
NCT00879645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium Sulfide is the first listed.
NCT00879645 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00879645's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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