A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1722; Drug: Renvela

• 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

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2014-09-24
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-27
• Last Update Posted: 2015-01-27

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