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NCT02536911 · ClinicalTrials.gov registry record · Phase 1
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02536911 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants.
The verdict
NCT02536911, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Primary Objective: To study the effect of mild and moderate hepatic 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 and moderate hepatic impairment in comparison with matched subjects with normal hepatic function.
Interventions
- DRUG eliglustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02536911
The ClinicalTrials.gov registry entry for NCT02536911 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which eliglustat is the first listed.
NCT02536911 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02536911 about?
NCT02536911 is a clinical study titled "A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate". Primary Objective: To study the effect of mild and moderate hepatic 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 and moderate hepatic impairment in comparison with matched...
What is the current status of trial NCT02536911?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02536911?
The interventions under investigation include: eliglustat (DRUG).
Who is sponsoring clinical trial NCT02536911?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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