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
1 other identifier
interventional
83
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedJune 27, 2014
June 1, 2014
5 months
November 11, 2013
June 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events
Measurement of safety laboratories, ECGs, vital signs, and physical exams
up to 3 weeks
Secondary Outcomes (2)
pharmacodynamic activity
up to one week
pharmacokinetics
up to one week
Study Arms (1)
AZD1722
EXPERIMENTALDose escalation from 5 mg to 90 mg BID
Interventions
Eligibility Criteria
You may qualify if:
- Healthy man or woman
- Body mass index between 18 and 29.9 kg/m2, inclusive
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardelyxlead
- AstraZenecacollaborator
Study Sites (1)
WCCT Global
Cypress, California, 90630, United States
Related Publications (1)
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.
PMID: 27368672DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
David P Rosenbaum, Ph.D.
Ardelyx, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2013
First Posted
June 27, 2014
Study Start
July 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 27, 2014
Record last verified: 2014-06