AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

September 18, 2015 updated by: Ardelyx

A Phase I, Single-centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C-labelled AZD1722 in Healthy Male Volunteers

To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers aged ≥50 years
  • Regular daily bowel movements.
  • Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg.

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
  • History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs.
  • Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre
  • Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre.
  • Volunteers exposed to radiation levels above background (eg, via X-ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life.
  • Participation in a previously radiolabelled study within the last 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD1722
Single oral dose 15 mg of [14C]AZD1722
Drug: AZD1722
Single oral dose 15 mg of [14C]AZD1722

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of radioactive dose recovered in urine and feces
Time Frame: Day 1: Pre-dose and up to 168 hours post-dose
Day 1: Pre-dose and up to 168 hours post-dose
Total percentage of radioactive dose recovered from both urine and feces
Time Frame: Day 1: Pre-dose and up to 168 hours post-dose
Day 1: Pre-dose and up to 168 hours post-dose
Concentration of total radioactivity in blood and plasma samples
Time Frame: Timeframe: Day 1: Predose and up to 120 hours
Timeframe: Day 1: Predose and up to 120 hours
Concentration of AZD1722 in plasma samples
Time Frame: Timeframe: Day 1: Predose and up to 120 hours
Timeframe: Day 1: Predose and up to 120 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)
Time Frame: up to 50 days
up to 50 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardelyx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • D5611C00007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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