Safety, Tolerability, Pharmacokinetics and Pharmacodynami... | NCT02176252

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

NCT02176252

Sponsor

Ardelyx

Status

Completed

Last Update Posted

Jun 27, 2014Estimated

Enrollment

83Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

AZD1722
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Jun 26, 2014

First Posted Date

Jun 27, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2014

Last Update Posted Date

Jun 27, 2014Estimated

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD1722	Experimental	Dose escalation from 5 mg to 90 mg BID	Drug: AZD1722 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD1722	Drug		AZD1722	RDX5791 Tenapanor
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David P Rosenbaum, Ph.D.	Ardelyx, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
WCCT Global		Cypress	California	90630	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27368672	Derived	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.