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NCT01975337 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
A Phase 1 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01975337 is a Phase 1 study that has completed, run by Debiopharm International. The registered enrollment target is 16 participants.
The verdict
NCT01975337, a Phase 1 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir when administered to subjects with ESRD.
Interventions
- DRUG Alisporivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01975337
The ClinicalTrials.gov registry entry for NCT01975337 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alisporivir is the first listed.
NCT01975337 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01975337 about?
NCT01975337 is a clinical study titled "Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects". The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects. The secondary objective was to evaluate the safety and tolerability of a single dose of alisporivir ...
What is the current status of trial NCT01975337?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-08. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01975337?
The interventions under investigation include: Alisporivir (DRUG).
Who is sponsoring clinical trial NCT01975337?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
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