Status:
COMPLETED
A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations
Lead Sponsor:
Ardelyx
Collaborating Sponsors:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief Summary
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.
Eligibility Criteria
Inclusion
- Healthy man or woman
- Body mass index between 18 and 29.9 kg/m2
Exclusion
- Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
- Any surgery on the small intestine or colon, excluding appendectomy or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02249936
Start Date
February 1 2013
End Date
February 1 2013
Last Update
September 26 2014
Active Locations (1)
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1
ICON Development Solutions
Omaha, Nebraska, United States, 68154