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OpenTrials
Completed

NCT Number: NCT02346890

A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.

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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

Healthcare Discoveries, LLC

San Antonio, Texas, 78209, 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 to the subject.

Treatment and study plan

AZD1722

Drug

Other names: RDX5791, Tenapanor

Renvela

Drug

Other names: Sevelamer carbonate

Primary outcomes

  1. Sodium levels in stool and urine

    Time frame: 4 days

    Pharmacodynamic activity

Secondary outcomes

  1. Evaluate the safety of AZD1722, measured by Adverse events

    Time frame: 8 days

    Adverse events

  2. Evaluate the safety of AZD1722, measured by clinical laboratory changes

    Time frame: 8 days

    clinical laboratory changes

  3. Plasma drug concentration to calculate AUC

    Time frame: 8 days

    Evaluate the Pharmacokinetics of AZD1722

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Phase 1, Single-center, Randomized, 2-way Crossover, Open Label Study to Evaluate the Effect of Renvela on the Pharmacodynamics of AZD1722 in Healthy Volunteeers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2015
Registry last updated
Jan 27, 2015

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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