Healthy Volunteer
Conditions
Brief summary
The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.
Interventions
DRUGAZD1722
DRUGPlacebo
Sponsors
AstraZeneca
Ardelyx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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, inclusive
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 * 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 to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | up to 3 weeks | Measurement of safety laboratories, ECGs, vital signs, and physical exams |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pharmacodynamic activity | up to one week | 24-hour stool sodium and phosphorus |
| pharmacokinetics | up to one week | plasma drug concentration to calculate AUC, if possible |
Countries
United States
Outcome results
None listed