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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: AZD1722

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD1722; Dose escalation from 5 mg to 90 mg BID	Drug: Placebo; 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	Measurement of safety laboratories, ECGs, vital signs, and physical exams	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacodynamic activity	24-hour stool sodium and phosphorus	up to one week
pharmacokinetics	plasma drug concentration to calculate AUC, if possible	up to one week

Collaborators and Investigators

• Sponsor: Ardelyx
• Collaborators: AstraZeneca

Publications and helpful links

General Publications

• Johansson S, Rosenbaum DP, Knutsson M, Leonsson-Zachrisson M. A phase 1 study of the safety, tolerability, pharmacodynamics, and pharmacokinetics of tenapanor in healthy Japanese volunteers. Clin Exp Nephrol. 2017 Jun;21(3):407-416. doi: 10.1007/s10157-016-1302-8. Epub 2016 Jul 1.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: D5611C00005