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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01284595
First received: January 26, 2011
Last updated: June 20, 2011
Last verified: June 2011
History of Changes

January 26, 2011
June 20, 2011
March 2011
May 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • To investigate the pharmacokinetic variable of AZD8931 in plasma [ Time Frame: Multiple PK blood samples from pre-dose until 240 hours post last dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01284595 on ClinicalTrials.gov Archive Site
  • To investigate the safety and tolerability of AZD8931 given orally [ Time Frame: Frequent safety measurements during the study from screening period to follow-up ] [ Designated as safety issue: Yes ]
  • To investigate the AZD8931 metabolites variables in plasma [ Time Frame: Multiple PK blood samples from pre-dose until 240 hours post last dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931
[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 to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: [14C] AZD8931
Single 160 mg oral dose administered on Day 1
Experimental: AZD8931
[14C] AZD8931
Intervention: Drug: [14C] AZD8931
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
May 2011
May 2011   (final data collection date for primary outcome measure)

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)
Male
50 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01284595
D0102C00007
No
Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Quintiles Drug Research Unit at Guy's Hospital
Study Director: Mary Stuart AstraZeneca
AstraZeneca
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP