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NCT01357811 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults
A Phase 1 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01357811 is a Phase 1 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 28 participants.
The verdict
NCT01357811, a Phase 1 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the effect of repeat oral doses of eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects. The study will comprise a screening period (between Day -45 and Day -2), treatment period 1 (Day -1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day 24 ± 1). There will be a 10-day washout between dosing of study drug in Period 1 and Period 2. The duration of each subject's participation in the study, inclusive of the screening and follow-up visits, will be approximately 10 weeks.
Interventions
- DRUG digoxin
- DRUG eliglustat; digoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01357811
The ClinicalTrials.gov registry entry for NCT01357811 describes a study currently listed as completed, 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 Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which digoxin is the first listed.
NCT01357811 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01357811 about?
NCT01357811 is a clinical study titled "A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults". The primary objective of this study is to determine the effect of repeat oral doses of eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This will be a single-site, open-labe...
What is the current status of trial NCT01357811?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-08. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01357811?
The interventions under investigation include: digoxin (DRUG), eliglustat; digoxin (DRUG).
Who is sponsoring clinical trial NCT01357811?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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