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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: Clinical Trial Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood pharmacokinetic samples will be collects at various timepoints to assess the MEK162 concentration levels. MEK162 concentrations and preliminary PK parameters will be analyzed in the two groups to determine if a dose adjustment is required in patients with moderate hepatic impairment
Interventions
- DRUG MEK162
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-08-26 |
| Phase | Phase 1 |
Why NCT02050815 stopped before completion
NCT02050815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which MEK162 is the first listed.
NCT02050815 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02050815's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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