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NCT02536937 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02536937 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 32 participants.
The verdict
NCT02536937, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Primary Objective: To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild, moderate, and severe renal impairment in comparison with matched subjects with normal renal function.
Interventions
- DRUG eliglustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-09 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02536937
The ClinicalTrials.gov registry entry for NCT02536937 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which eliglustat is the first listed.
NCT02536937 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02536937 about?
NCT02536937 is a clinical study titled "A Study of the Effects of Renal Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate". Primary Objective: To study the effect of mild, moderate, and severe renal impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild, moderate, and severe renal impairment in compariso...
What is the current status of trial NCT02536937?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-09. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02536937?
The interventions under investigation include: eliglustat (DRUG).
Who is sponsoring clinical trial NCT02536937?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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