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OpenTrials
Completed

NCT Number: NCT01284595

Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931

Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration

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Key information

Conditions

Healthy

Age range

50 year–65 year

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 ≥19 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-smokers or ex-smokers who have stopped smoking for >3 months before Visit 1 and have not used nicotine products for >3 months
  • Healthy Male volunteers aged 50 to 65 years, inclusive

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 12 months of the screening visit (Visit 1).
  • History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)

Treatment and study plan

[14C] AZD8931

Drug

Single 160 mg oral dose administered on Day 1

Primary outcomes

  1. To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects

    Time frame: Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose

  2. To investigate the pharmacokinetic variable of AZD8931 in plasma

    Time frame: Multiple PK blood samples from pre-dose until 240 hours post last dose

Secondary outcomes

  1. To investigate the safety and tolerability of AZD8931 given orally

    Time frame: Frequent safety measurements during the study from screening period to follow-up

  2. To investigate the AZD8931 metabolites variables in plasma

    Time frame: Multiple PK blood samples from pre-dose until 240 hours post last dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

[14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2011
Registry last updated
Aug 13, 2014

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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