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NCT01456663 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects
A Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
- 3
- Study locations
NCT01456663: Completed Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
NCT01456663 is a Phase 1 study of Hepatic Impairment that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 118 participants, above the 34-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (247% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456663, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
Primary Outcome
AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F
Conditions Studied
Interventions
- DRUG AFQ056
Study Locations (3)
Other
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Balatonfüred
Florida
- Novartis Investigative Site - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01456663 record still lists
NCT01456663 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, above the 34-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (247% higher).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which AFQ056 is the first listed.
NCT01456663 reports a single indexed study location in Other, Florida.
Frequently Asked Questions
What is clinical trial NCT01456663 about?
NCT01456663 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects". This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.
What is the current status of trial NCT01456663?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2011-05. Estimated completion is 2012-07.
What conditions does trial NCT01456663 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT01456663?
The interventions under investigation include: AFQ056 (DRUG).
Who is sponsoring clinical trial NCT01456663?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01456663 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01456663's enrollment target sits among peer trials
118 2nd of 48 the highest of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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.
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