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

Sponsor
Ardelyx (Industry)
Overall Status
Completed
CT.gov ID
NCT02346890
Collaborator
AstraZeneca (Industry)
16
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sodium levels in stool and urine [4 days]

      Pharmacodynamic activity

    Secondary Outcome Measures

    1. Evaluate the safety of AZD1722, measured by Adverse events [8 days]

      Adverse events

    2. Evaluate the safety of AZD1722, measured by clinical laboratory changes [8 days]

      clinical laboratory changes

    3. Plasma drug concentration to calculate AUC [8 days]

      Evaluate the Pharmacokinetics of AZD1722

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Healthcare Discoveries, LLC San Antonio Texas United States 78209

    Sponsors and Collaborators

    • Ardelyx
    • AstraZeneca

    Investigators

    • Study Director: David P Rosenbaum, Ph.D., Ardelyx, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ardelyx
    ClinicalTrials.gov Identifier:
    NCT02346890
    Other Study ID Numbers:
    • D5611C00006
    First Posted:
    Jan 27, 2015
    Last Update Posted:
    Jan 27, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Ardelyx
    Volunteer
    Additional relevant MeSH terms:
    Sevelamer

    Study Results

    No Results Posted as of Jan 27, 2015