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D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects

NCT02226783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-09-22

No results posted yet for this study

Summary

Study to evaluate the effect of intake of food in comparison to fasting condition on pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet formulation

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

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • David Mathews, MD · Quintiles Phase I Services, LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02226783 on ClinicalTrials.gov