NCT02346890

Brief Summary

The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

September 24, 2014

Last Update Submit

January 26, 2015

Conditions

Healthy

Keywords

Volunteer

Outcome Measures

Primary Outcomes (1)

  • Sodium levels in stool and urine

    Pharmacodynamic activity

    4 days

Secondary Outcomes (3)

  • Evaluate the safety of AZD1722, measured by Adverse events

    8 days

  • Evaluate the safety of AZD1722, measured by clinical laboratory changes

    8 days

  • Plasma drug concentration to calculate AUC

    8 days

Study Arms (2)

AZD1722 alone

EXPERIMENTAL

15 mg BID

Drug: AZD1722

AD1722 with Renvela

EXPERIMENTAL

AZD1722 15 mg BID and Renvela 800 mg TID

Drug: AZD1722Drug: Renvela

Interventions

AZD1722DRUG
Also known as: RDX5791, Tenapanor
AD1722 with RenvelaAZD1722 alone
RenvelaDRUG
Also known as: Sevelamer carbonate
AD1722 with Renvela

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy man or woman
  • Body mass index between 18 and 29.9 kg/m2

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 or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • 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

Study Sites (1)

Healthcare Discoveries, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

tenapanorSevelamer

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • David P Rosenbaum, Ph.D.

    Ardelyx, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

January 27, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

US(1)