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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: Completed Phase 1 study, sponsored by Debiopharm International.
NCT01975337 is a Phase 1 study that has completed, run by Debiopharm International. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01975337 record still lists
NCT01975337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Alisporivir is the first listed.
NCT01975337 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01975337's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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