A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722
- Registration Number
- NCT02346890
- Lead Sponsor
- Ardelyx
- Brief Summary
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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 to the subject.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AD1722 with Renvela AZD1722 AZD1722 15 mg BID and Renvela 800 mg TID AZD1722 alone AZD1722 15 mg BID AD1722 with Renvela Renvela AZD1722 15 mg BID and Renvela 800 mg TID
- Primary Outcome Measures
Name Time Method Sodium levels in stool and urine 4 days Pharmacodynamic activity
- Secondary Outcome Measures
Name Time Method Evaluate the safety of AZD1722, measured by Adverse events 8 days Adverse events
Evaluate the safety of AZD1722, measured by clinical laboratory changes 8 days clinical laboratory changes
Plasma drug concentration to calculate AUC 8 days Evaluate the Pharmacokinetics of AZD1722
Trial Locations
- Locations (1)
Healthcare Discoveries, LLC
🇺🇸San Antonio, Texas, United States