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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01284595
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C] AZD8931 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official 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
Study Start Date : March 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: AZD8931
[14C] AZD8931
Drug: [14C] AZD8931
Single 160 mg oral dose administered on Day 1

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01284595

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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Darren Wilbraham, MBBS, DCPSA Quintiles Drug Research Unit at Guy's Hospital
Study Director: Mary Stuart AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT01284595     History of Changes
Other Study ID Numbers: D0102C00007
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by AstraZeneca:
Radioactive carbon
Healthy Volunteers