NCT02050815 (MEK162) is a Phase 1 clinical trial of MEK162 in Hepatic Impairment, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

Who is sponsoring NCT02050815?

NCT02050815 is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

What drugs are being tested in NCT02050815?

Interventions in NCT02050815: MEK162.

What condition does NCT02050815 study?

NCT02050815 studies Hepatic Impairment.

Is NCT02050815 still recruiting?

NCT02050815 is currently terminated. Last updated 16 September 2020.

Last reviewed 2020-09-16 · How we verify

NCT02050815: MEK162

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of MEK162 in Subjects With Mild, Moderate and Severe Hepatic Impairment

Terminated Phase 1 Last updated 16 September 2020

What this trial tests

Phase 1 trial testing MEK162 in Hepatic Impairment in 27 participants. Terminated before completion.

Timeline

1 March 2014

Primary endpoint
1 August 2016

26 August 2016

Quick facts

Lead sponsor	Array Biopharma, now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 March 2014
Primary completion	1 August 2016
Estimated completion	26 August 2016
Sites	5 locations across United States

Drugs / interventions tested

MEK162 (mek162) — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

PK parameters assessed by Tmax
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120
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
PK parameters assessed by Cmax
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120
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
PK parameters assessed by AUCinf
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120
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
PK parameters assessed by AUC0last
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120
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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Reviewing the role of healthy volunteer studies in drug development.
Karakunnel JJ, Bui N, Palaniappan L, Schmidt KT, et al · · 2018 · cited 33× · PMID 30509294 · DOI 10.1186/s12967-018-1710-5
Pharmacokinetics of Binimetinib in Participants with Hepatic Impairment.
Piscitelli J, Hahn E, Wollenberg L, Chavira R, et al · · 2025 · PMID 40549341 · DOI 10.1007/s40262-025-01509-0

Verify or expand the search:

Other trials of MEK162

Trials testing the same drug.

NCT03158103 — A Study of MEK162 (Binimetinib) in Combination With Pexidartinib in Patients With Advanced Gastrointestinal Stromal Tumo · Phase 1 · completed
NCT02631447 — Sequential Combo Immuno and Target Therapy (SECOMBIT) Study · Phase 2 · completed
NCT02285439 — Study of MEK162 for Children With Low-Grade Gliomas · Phase 1, PHASE2 · completed
NCT02276027 — A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advance · Phase 2 · completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma · Phase 2 · completed

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Array Biopharma, now a wholly owned subsidiary of Pfizer trials

Trials by the same sponsor.

NCT00790049 — A Safety Study of ARRY-371797 in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02050815 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Array Biopharma, now a wholly owned subsidiary of Pfizer
Last refreshed: 16 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02050815.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing