A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations
A Phase 1, Single-Center, Randomized, 3-Way Cross-Over, Open Label Study to Evaluate the Pharmacodynamics of Different Formulations of AZD1722 in Healthy Volunteers Taking Omeprazole
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Feb 2013
1 active site
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
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedSeptember 26, 2014
September 1, 2014
Same day
September 24, 2014
September 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events
Measurement of safety laboratories, ECGs, vitals signs and physical exams
8 days
Secondary Outcomes (2)
Sodium levels in stool and urine
8 days
Plasma drug concentration to calculate AUC
8 days
Study Arms (3)
AZD1722 HCl Capsule
EXPERIMENTAL15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
AZD1722 HCl Tablet
EXPERIMENTAL15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
AZD1722 Free-base Tablet
EXPERIMENTAL15 mg bid AZD1722 and 20 mg bid Omeprazole
Interventions
Eligibility Criteria
You may qualify if:
- Healthy man or woman
- Body mass index between 18 and 29.9 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardelyxlead
- AstraZenecacollaborator
Study Sites (1)
ICON Development Solutions
Omaha, Nebraska, 68154, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David P Rosenbaum, Ph.D.
Ardelyx, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2014
First Posted
September 26, 2014
Study Start
February 1, 2013
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
September 26, 2014
Record last verified: 2014-09