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Completed

NCT Number: NCT01332903

Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C] AZD5069.

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Key information

Conditions

Healthy

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

  • Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
  • Regular daily bowel movements (ie, production of at least 1 stool per day).
  • Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
  • Healthy Male volunteers aged 50 and over

Exclusion criteria

  • Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
  • Participation in any prior radiolabelled study within last 5 years
  • History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Treatment and study plan

[14C] AZD5069

Drug

Single 120 mg oral dose administered on Day 1

Primary outcomes

  1. To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood

    Time frame: From pre-dose until 168 hours post last dose

    To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).

  2. To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax).

    Time frame: From pre-dose until 168hours post last dose

  3. To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance.

    Time frame: From pre-dose until 168hours post last dose

Secondary outcomes

  1. To investigate the safety and tolerability of AZD5069 given orally

    Time frame: From screening visit, Day 12, up to follow up visit

    Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 11, 2011
Registry last updated
Jun 25, 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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