Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects
- Registration Number
- NCT02176252
- Lead Sponsor
- Ardelyx
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AZD1722 Placebo Dose escalation from 5 mg to 90 mg BID AZD1722 AZD1722 Dose escalation from 5 mg to 90 mg BID
- Primary Outcome Measures
Name Time Method Number of patients with adverse events up to 3 weeks Measurement of safety laboratories, ECGs, vital signs, and physical exams
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
WCCT Global
🇺🇸Cypress, California, United States