NCT02176252

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Ardelyx · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AZD1722
DRUG	Placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-06-27
• Last updated: 2014-06-27

Locations

1 site across 1 country: United States