D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Healthy Volunteers Food Interaction Study
Interventions
DRUG

AZD1722 salt tablet

AZD1722 will be administered as 14 mg (salt tablet). tablet for oral use. Subjects will receive a 14 mg tablet in the morning and evening on Days 1 to 4 (Period 1), Days 7 to 10 (Period 2), and Days 13 to 16 (Period 3).

DRUG

AZD1722 free base tablet

AZD1722 will be given as four 14 mg free-base tablets (56mg) in the morning and evening on Days 1 to 4 (Period 1) and Days 10 to 13 (Period 2).

DRUG

AZD1722 free base tablet + Omeprazole

AZD1722 free base tablet administered 5 to 10 minutes before intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722

Trial Locations (1)

KS 66211

Research Site, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ardelyx

INDUSTRY