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OpenTrials
Completed

NCT Number: NCT02249936

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

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

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Key information

Conditions

Healthy

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Development Solutions

Omaha, Nebraska, 68154, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1722

Drug

Other names: Tenapanor, RDX5791

Omeprazole

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 8 days

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

Secondary outcomes

  1. Sodium levels in stool and urine

    Time frame: 8 days

    Pharmacodynamic activity

  2. Plasma drug concentration to calculate AUC

    Time frame: 8 days

    Pharmacokinetics

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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