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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: AZD1722
  • Drug: Omeprazole

Arms, Groups and Cohorts

  • Experimental: AZD1722 HCl Capsule
    • 15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
  • Experimental: AZD1722 HCl Tablet
    • 15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
  • Experimental: AZD1722 Free-base Tablet
    • 15 mg bid AZD1722 and 20 mg bid Omeprazole

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients with adverse events
    • Time Frame: 8 days
    • Measurement of safety laboratories, ECGs, vitals signs and physical exams

Secondary Measures

  • Sodium levels in stool and urine
    • Time Frame: 8 days
    • Pharmacodynamic activity
  • Plasma drug concentration to calculate AUC
    • Time Frame: 8 days
    • Pharmacokinetics

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ardelyx
  • Collaborator
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David P Rosenbaum, Ph.D., Study Director, Ardelyx, Inc

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