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OpenTrials
Completed

NCT Number: NCT02063386

AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study

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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1722

Drug

Single oral dose 15 mg of [14C]AZD1722

Primary outcomes

  1. Percentage of radioactive dose recovered in urine and feces

    Time frame: Day 1: Pre-dose and up to 168 hours post-dose

  2. Total percentage of radioactive dose recovered from both urine and feces

    Time frame: Day 1: Pre-dose and up to 168 hours post-dose

  3. Concentration of total radioactivity in blood and plasma samples

    Time frame: Timeframe: Day 1: Predose and up to 120 hours

  4. Concentration of AZD1722 in plasma samples

    Time frame: Timeframe: Day 1: Predose and up to 120 hours

Secondary outcomes

  1. Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)

    Time frame: up to 50 days

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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