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Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

Sponsor
Ardelyx (Industry)
Overall Status
Completed
CT.gov ID
NCT02176252
Collaborator
AstraZeneca (Industry)
83
Enrollment
1
Location
1
Arm
5
Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects in Healthy Male and Female Japanese Subjects After Single and Multiple Doses (Bid) of AZD1722
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: AZD1722

Dose escalation from 5 mg to 90 mg BID

Drug: AZD1722
Other Names:
  • RDX5791
  • Tenapanor

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with adverse events [up to 3 weeks]

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

    Secondary Outcome Measures

    1. pharmacodynamic activity [up to one week]

      24-hour stool sodium and phosphorus

    2. pharmacokinetics [up to one week]

      plasma drug concentration to calculate AUC, if possible

    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, inclusive

    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

    • 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 WCCT Global Cypress California United States 90630

    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:
    NCT02176252
    Other Study ID Numbers:
    • D5611C00005
    First Posted:
    Jun 27, 2014
    Last Update Posted:
    Jun 27, 2014
    Last Verified:
    Jun 1, 2014

    Study Results

    No Results Posted as of Jun 27, 2014