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NCT01716455 · ClinicalTrials.gov registry record · Phase 1
Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT01716455 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 66 participants.
The verdict
NCT01716455, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.
Interventions
- DRUG SSP-004184
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-10-29 |
| Est. Completion | 2013-03-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01716455
The ClinicalTrials.gov registry entry for NCT01716455 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SSP-004184 is the first listed.
NCT01716455 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01716455 about?
NCT01716455 is a clinical study titled "Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function". Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg d...
What is the current status of trial NCT01716455?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2012-10-29. Estimated completion is 2013-03-10.
What interventions are being tested in trial NCT01716455?
The interventions under investigation include: SSP-004184 (DRUG).
Who is sponsoring clinical trial NCT01716455?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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