Healthy
Conditions
Keywords
Volunteers
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.
Interventions
DRUGAZD1722
DRUGOmeprazole
Sponsors
AstraZeneca
Ardelyx
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy man or woman * Body mass index between 18 and 29.9 kg/m2
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | 8 days | Measurement of safety laboratories, ECGs, vitals signs and physical exams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sodium levels in stool and urine | 8 days | Pharmacodynamic activity |
| Plasma drug concentration to calculate AUC | 8 days | Pharmacokinetics |
Countries
United States
Outcome results
None listed