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NCT02050815 · ClinicalTrials.gov registry record · Phase 1
MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
A Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02050815 is a Phase 1 study that was terminated before completion, run by Array Biopharma, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 27 participants.
The verdict
NCT02050815, a Phase 1 study, was terminated before completion, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with normal hepatic function. Subjects will be assigned by hepatic function defined by elevation of serum total bilirubin and serum AST as determined at the screening and baseline visits. The study population will be healthy male and postmenopausal or sterile female subjects who meet all of the inclusion and none of the exclusion criteria. A minimum of 24 evaluable subjects (6 subjects per group) will be enrolled. The groups are: Group 1-healthy volunteers, Group 2-Mild hepatic impairment, Group 3-Moderate hepatic impairment and Group 4-Severe hepatic impairment. Once approved for enrollment, participants will be confined to the facility for 5 days, given a single dose of MEK162 and monitored for safety assessments, labs and PK will be assessed.
Interventions
- DRUG MEK162
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-08-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02050815
The ClinicalTrials.gov registry entry for NCT02050815 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MEK162 is the first listed.
NCT02050815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02050815 about?
NCT02050815 is a clinical study titled "MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function". This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with normal hepatic function. Subjects will be assigned by hepatic function defined by elevation of serum to...
What is the current status of trial NCT02050815?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2014-03. Estimated completion is 2016-08-26.
What interventions are being tested in trial NCT02050815?
The interventions under investigation include: MEK162 (DRUG).
Who is sponsoring clinical trial NCT02050815?
This trial is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total clinical trials registered on ClinicalTrials.gov.
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