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A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations

Sponsor
Ardelyx (Industry)
Overall Status
Completed
CT.gov ID
NCT02249936
Collaborator
AstraZeneca (Industry)
18
Enrollment
1
Location
3
Arms

Study Details

Study Description

Brief Summary

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of different formulations of AZD1722 in healthy male and female subjects taking Omeprazole.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Single-Center, Randomized, 3-Way Cross-Over, Open Label Study to Evaluate the Pharmacodynamics of Different Formulations of AZD1722 in Healthy Volunteers Taking Omeprazole
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: AZD1722 HCl Capsule

15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

Drug: AZD1722
Other Names:
  • Tenapanor
  • RDX5791

    • Drug: Omeprazole
    Experimental: AZD1722 HCl Tablet

    15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

    Drug: AZD1722
    Other Names:
  • Tenapanor
  • RDX5791

    • Drug: Omeprazole
    Experimental: AZD1722 Free-base Tablet

    15 mg bid AZD1722 and 20 mg bid Omeprazole

    Drug: AZD1722
    Other Names:
  • Tenapanor
  • RDX5791

    • Drug: Omeprazole

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with adverse events [8 days]

      Measurement of safety laboratories, ECGs, vitals signs and physical exams

    Secondary Outcome Measures

    1. Sodium levels in stool and urine [8 days]

      Pharmacodynamic activity

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

      Pharmacokinetics

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICON Development Solutions Omaha Nebraska United States 68154

    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:
    NCT02249936
    Other Study ID Numbers:
    • D5611C00002
    First Posted:
    Sep 26, 2014
    Last Update Posted:
    Sep 26, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Ardelyx
    Volunteers
    Additional relevant MeSH terms:
    Omeprazole

    Study Results

    No Results Posted as of Sep 26, 2014