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

January 26, 2015 updated by: Ardelyx

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

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Healthcare Discoveries, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD1722 alone
15 mg BID
Drug: AZD1722
Other Names:
  • RDX5791
  • Tenapanor
Experimental: AD1722 with Renvela
AZD1722 15 mg BID and Renvela 800 mg TID
Drug: AZD1722
Other Names:
  • RDX5791
  • Tenapanor
Drug: Renvela
Other Names:
  • Sevelamer carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sodium levels in stool and urine
Time Frame: 4 days
Pharmacodynamic activity
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety of AZD1722, measured by Adverse events
Time Frame: 8 days
Adverse events
8 days
Evaluate the safety of AZD1722, measured by clinical laboratory changes
Time Frame: 8 days
clinical laboratory changes
8 days
Plasma drug concentration to calculate AUC
Time Frame: 8 days
Evaluate the Pharmacokinetics of AZD1722
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardelyx

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5611C00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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