To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Solid Tumours
Interventions
DRUG

selumetinib

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

DRUG

itraconazole

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

DRUG

itraconazole

Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.

DRUG

selumetinib

Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.

DRUG

selumetinib

Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.

DRUG

fluconazole

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.

DRUG

fluconazole

Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E

DRUG

selumetinib

Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E

Trial Locations (1)

Unknown

Research Site, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY