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

NCT ID: NCT02249936

Last Updated: 2014-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-02-28

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD1722 HCl Capsule

15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

Group Type EXPERIMENTAL

AZD1722

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

AZD1722 HCl Tablet

15 mg bid AZD1722 HCl and 20 mg bid Omeprazole

Group Type EXPERIMENTAL

AZD1722

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

AZD1722 Free-base Tablet

15 mg bid AZD1722 and 20 mg bid Omeprazole

Group Type EXPERIMENTAL

AZD1722

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Interventions

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AZD1722

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Other Intervention Names

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Tenapanor RDX5791

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Ardelyx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David P Rosenbaum, Ph.D.

Role: STUDY_DIRECTOR

Ardelyx, Inc

Locations

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ICON Development Solutions

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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D5611C00002

Identifier Type: -

Identifier Source: org_study_id

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