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NCT02857868 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
A Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 3
- Study locations
NCT02857868: Completed Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
NCT02857868 is a Phase 1 study of Hepatic Impairment that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 32 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02857868, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 3
- Study locations
Study Summary
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
Primary Outcome
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects
Conditions Studied
Interventions
- DRUG ABL001
Study Locations (3)
Florida
- University of Miami / Clinical Research Services, Inc. - Miami
- Orlando Clinical Research Center - Orlando
Minnesota
- DaVita Clinical Research - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-05-03 |
| Est. Completion | 2017-07-20 |
| Phase | Phase 1 |
What the finished NCT02857868 record still lists
NCT02857868 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 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which ABL001 is the first listed.
NCT02857868 reports a single indexed study location in Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02857868 about?
NCT02857868 is a clinical study titled "A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects". The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
What is the current status of trial NCT02857868?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-05-03. Estimated completion is 2017-07-20.
What conditions does trial NCT02857868 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT02857868?
The interventions under investigation include: ABL001 (DRUG).
Who is sponsoring clinical trial NCT02857868?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02857868 being conducted?
This trial has 3 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
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 NCT02857868's enrollment target sits among peer trials
32 13th of 48 higher than 30 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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