Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01860326
The ClinicalTrials.gov registry entry for NCT01860326 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 38-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (16% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
-
A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function
RECRUITING · Phase 1
-
A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems
RECRUITING · Phase 1
-
A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.
RECRUITING · Phase 1
-
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
COMPLETED · Phase 1
-
A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
COMPLETED · Phase 1
-
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.