NCT02346890
Completed
Phase 1
A Phase 1, Single-center, Randomized, 2-way Crossover, Open Label Study to Evaluate the Effect of Renvela on the Pharmacodynamics of AZD1722 in Healthy Volunteeers
Overview
- Phase
- Phase 1
- Intervention
- AZD1722
- Conditions
- Healthy
- Sponsor
- Ardelyx
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Sodium levels in stool and urine
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.
Investigators
Eligibility Criteria
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.
Arms & Interventions
AZD1722 alone
15 mg BID
Intervention: AZD1722
AD1722 with Renvela
AZD1722 15 mg BID and Renvela 800 mg TID
Intervention: AZD1722
AD1722 with Renvela
AZD1722 15 mg BID and Renvela 800 mg TID
Intervention: Renvela
Outcomes
Primary Outcomes
Sodium levels in stool and urine
Time Frame: 4 days
Pharmacodynamic activity
Secondary Outcomes
- Evaluate the safety of AZD1722, measured by Adverse events(8 days)
- Evaluate the safety of AZD1722, measured by clinical laboratory changes(8 days)
- Plasma drug concentration to calculate AUC(8 days)
Study Sites (1)
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