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Completed

NCT Number: NCT02176252

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects

The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.

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Key information

Conditions

Healthy Volunteer

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global

Cypress, California, 90630, 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, inclusive

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
  • 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

Placebo

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: up to 3 weeks

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

Secondary outcomes

  1. pharmacodynamic activity

    Time frame: up to one week

    24-hour stool sodium and phosphorus

  2. pharmacokinetics

    Time frame: up to one week

    plasma drug concentration to calculate AUC, if possible

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

A Phase I, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects in Healthy Male and Female Japanese Subjects After Single and Multiple Doses (Bid) of AZD1722

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2014
Registry last updated
Jun 27, 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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