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NCT01860326 · ClinicalTrials.gov registry record · Phase 1
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
A Phase 1 study of Hepatic Insufficiency, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT01860326: Completed Phase 1 study of Hepatic Insufficiency, sponsored by Debiopharm International.
NCT01860326 is a Phase 1 study of Hepatic Insufficiency that has completed, run by Debiopharm International. The registered enrollment target is 32 participants, below the 38-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (16% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01860326, a Phase 1 study of Hepatic Insufficiency, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.
Conditions Studied
Interventions
- DRUG Alisporivir
Study Locations (2)
Florida
- University of Miami - Miami
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
What the finished NCT01860326 record still lists
NCT01860326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 38-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Hepatic Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Alisporivir is the first listed.
NCT01860326 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01860326 about?
NCT01860326 is a clinical study titled "Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects". This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal liver function.
What is the current status of trial NCT01860326?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-03. Estimated completion is 2011-09.
What conditions does trial NCT01860326 study?
This clinical trial studies the following conditions: Hepatic Insufficiency.
What interventions are being tested in trial NCT01860326?
The interventions under investigation include: Alisporivir (DRUG).
Who is sponsoring clinical trial NCT01860326?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01860326 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Insufficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01860326's enrollment target sits among peer trials
32 8th of 14 higher than 4 of 14 other Hepatic Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Insufficiency 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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