NCT02093728

Brief Summary

Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142866) ( 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
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2014

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

March 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 30, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

March 20, 2014

Last Update Submit

June 29, 2015

Conditions

Solid Tumours

Keywords

Phase I, healthy, pharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

    Samples taken during each of the 6 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, 48, 72 and 96 hours post dose

Secondary Outcomes (12)

  • Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assesement of area under the plasma concentration-time from time zero to the time of the last quantifiable 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, 48, 72 and 96 hours post dose

  • Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assesement of area under the plasma concentration-time curve from time zero to 12 hours post-dose 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, 48, 72 and 96 hours post dose

  • Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assesement of maximum plasma concentration (Cmax)

    Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours post dose

  • Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assesement 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, 48, 72 and 96 hours post dose

  • Pharmacokinetics of selumetinib by assesement of apparent oral 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, 48, 72 and 96 hours post dose

  • +7 more secondary outcomes

Other Outcomes (1)

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

    Baseline (Day-1) up to Day 24

Study Arms (2)

selumetinib; itraconazole; selumetinib + itraconazole

EXPERIMENTAL

Volunteers will receive selumetinib 25mg alone; itraconazole 200mg pre-dosing; selumetinib 25mg and itraconazole 200mg; all adminstered by mouth as a capsule

Drug: selumetinibDrug: itraconazole

selumetinib; fluconazole; selumetinib + fluconazole

EXPERIMENTAL

Volunteers will receive selumetinib 25mg alone administered by mouth as a capsule; fluconazole 400mg and fluconazole 200mg pre-dosing, administered by mouth as a tablet; selumetinib 25mg and fluconazole 200mg.

Drug: selumetinibDrug: fluconazole

Interventions

selumetinibDRUG

Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A

Also known as: (AZD6244; ARRY-142866) ( Hyd-Sulfate)
selumetinib; itraconazole; selumetinib + itraconazole
itraconazoleDRUG

Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:

selumetinib; itraconazole; selumetinib + itraconazole
fluconazoleDRUG

Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.

selumetinib; fluconazole; selumetinib + fluconazole

Eligibility Criteria

Age18 Years - 45 Years
Sexall
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 Links

MeSH Terms

Interventions

AZD 6244ItraconazoleFluconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • David R Mathews, 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 21, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 30, 2015

Record last verified: 2015-06

Locations

US(1)