NCT02046850

Brief Summary

Study to assess the effect of Rifampicin 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
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 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

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

January 24, 2014

Last Update Submit

April 28, 2014

Conditions

Solid Tumours

Keywords

Phase I, healthy, pharmacokinetics,

Outcome Measures

Primary Outcomes (1)

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

    Samples taken during each of the 3 treatments

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

Secondary Outcomes (12)

  • Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment 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, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose

  • Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment 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, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose

  • Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of maximum plasma concentration (Cmax)

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

  • Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of time to Cmax (tmax)

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

  • 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, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose

  • +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 25

Study Arms (3)

selumetinib 75mg.

EXPERIMENTAL

Volunteers will receive selumetinib 75mg administered by mouth, as a capsule

Drug: selumetinib

rifampicin 600mg.

OTHER

Volunteers will receive rifampicin 600mg administered by mouth, as a capsule

Drug: rifampicin

selumetinib 75mg and rifampicin 600mg

EXPERIMENTAL

Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule

Drug: selumetinibDrug: rifampicin

Interventions

selumetinibDRUG

Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A).

Also known as: AZD6244
selumetinib 75mg.
rifampicinDRUG

Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).

Also known as: AZD6244
rifampicin 600mg.

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

MeSH Terms

Interventions

AZD 6244Rifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Eleanor Lisbon, MD

    Quintiles 6700 W 115th Street, Kansas, US

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-04

Locations

US(1)