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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176252
• Other study ID #: D5611C00005
• Status: Completed
• Phase: Phase 1
• First received: November 11, 2013
• Last updated: June 26, 2014
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD1722

• Placebo

Locations

Country	Name	City	State
United States	WCCT Global	Cypress	California

Sponsors (2)

Lead Sponsor	Collaborator
Ardelyx	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events	Measurement of safety laboratories, ECGs, vital signs, and physical exams	up to 3 weeks	Yes
Secondary	pharmacodynamic activity	24-hour stool sodium and phosphorus	up to one week	No
Secondary	pharmacokinetics	plasma drug concentration to calculate AUC, if possible	up to one week	No