NCT01974349

Brief Summary

Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

3 months

First QC Date

October 28, 2013

Last Update Submit

August 12, 2014

Conditions

Solid Tumours

Keywords

Phase I, healthy, pharmacokinetics, food effect.

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of selumetinib and N desmethyl selumetinib, by assessment of maximum plasma concentration (Cmax)

    Curve taken during each of the 2 treatments

    Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose

Secondary Outcomes (12)

  • Pharmacokinetics of selumetinib and N desmethyl selumetinib, by assessment of the area under the plasma concentration-time curve from time zero to infinity (AUC)

    Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose

  • Pharmacokinetics of selumetinib and N desmethyl selumetinib, by assessment of the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration AUC(0-t)

    Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose

  • Pharmacokinetics of selumetinib and N desmethyl selumetinib, by assessment of area under the plasma concentration-time curve from time zero to 12 hours postdose AUC (0-12)

    Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose

  • Pharmacokinetics of selumetinib and N desmethyl selumetinib, by assessment of time to Cmax (tmax)

    Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose

  • Pharmacokinetics of selumetinib by assessment of apparent systemic plasma clearance (CL/F)

    Blood samples are collected pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, and 48 hours postdose

  • +7 more secondary outcomes

Other Outcomes (1)

  • Safety variables (adverse events, physical examinations, ophthalmologic assessments, vital signs, clinical laboratory assessments, and 12 lead electrocardiograms)

    Baseline (Day-1) up to Day 24

Study Arms (2)

selumetinib 75mg (oral capsule fasted)

EXPERIMENTAL

Volunteers will recieve selumetinib 75mg administered by mouth, as a capsule, in a fasted state.

Drug: selumetinib (oral)

selumetinib 75mg (oral capusle fed)

EXPERIMENTAL

Volunteers will receive selumetinib 75mg administered by mouth, as a capsule, in a fed state.

Drug: selumetinib (oral)

Interventions

selumetinib (oral)DRUG

Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses.

Also known as: AZD6244
selumetinib 75mg (oral capsule fasted)selumetinib 75mg (oral capusle fed)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • Tomkinson H, McBride E, Martin P, Lisbon E, Dymond AW, Cantarini M, So K, Holt D. Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects. Clin Ther. 2017 Nov;39(11):2260-2275.e1. doi: 10.1016/j.clinthera.2017.08.022. Epub 2017 Oct 4.

    PMID: 28985960DERIVED

MeSH Terms

Interventions

AZD 6244

Study Officials

  • Eleanor Lisbon, MD

    Quintiles 6700 W 115th Street, Kansas, US

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 1, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

US(1)