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NCT02521376 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
A Phase 1 study of Oncology, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 6
- Study locations
NCT02521376: Completed Phase 1 study of Oncology, sponsored by Gilead Sciences.
NCT02521376 is a Phase 1 study of Oncology that has completed, run by Gilead Sciences. The registered enrollment target is 56 participants, below the 525-participant average among 24 other Oncology trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02521376, a Phase 1 study of Oncology, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
Primary Outcome
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Conditions Studied
Interventions
- DRUG Entospletinib
Study Locations (6)
Florida
- Clinical Pharmacology of Miami, Inc. (CPMI) - Miami
- Orlando Clinical Research Center - Orlando
Other
- APEX GmBH - Munich
- Auckland Clinical Studies - Auckland
Minnesota
- DaVita Clinical Research - Minneapolis
Texas
- The Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2017-10-25 |
| Phase | Phase 1 |
What the finished NCT02521376 record still lists
NCT02521376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 525-participant average among 24 other Oncology trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Oncology appearing as the primary indexed condition, and to 1 intervention - of which Entospletinib is the first listed.
NCT02521376 lists 6 locations in 4 states (Florida, Other, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02521376 about?
NCT02521376 is a clinical study titled "Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function". The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
What is the current status of trial NCT02521376?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2015-11-16. Estimated completion is 2017-10-25.
What conditions does trial NCT02521376 study?
This clinical trial studies the following conditions: Oncology.
What interventions are being tested in trial NCT02521376?
The interventions under investigation include: Entospletinib (DRUG).
Who is sponsoring clinical trial NCT02521376?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02521376 being conducted?
This trial has 6 study locations across Florida, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02521376's enrollment target sits among peer trials
56 18th of 24 higher than 7 of 24 other Oncology trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oncology 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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