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

September 25, 2014 updated by: Ardelyx

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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
    • Nebraska
      • Omaha, Nebraska, United States, 68154
        • ICON Development Solutions

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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD1722 HCl Capsule
15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
Drug: Omeprazole
Drug: AZD1722
Other Names:
  • RDX5791
  • Tenapanor
Experimental: AZD1722 HCl Tablet
15 mg bid AZD1722 HCl and 20 mg bid Omeprazole
Drug: Omeprazole
Drug: AZD1722
Other Names:
  • RDX5791
  • Tenapanor
Experimental: AZD1722 Free-base Tablet
15 mg bid AZD1722 and 20 mg bid Omeprazole
Drug: Omeprazole
Drug: AZD1722
Other Names:
  • RDX5791
  • Tenapanor

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ardelyx

Collaborators

AstraZeneca

Investigators

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

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

February 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5611C00002

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.

Clinical Trials on Healthy

Clinical Trials on Omeprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe