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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: [14C] AZD8931
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 6
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD8931
[14C] AZD8931
Drug: [14C] AZD8931
Single 160 mg oral dose administered on Day 1

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284595

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

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01284595     History of Changes
Other Study ID Numbers: D0102C00007
Study First Received: January 26, 2011
Last Updated: June 20, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Radioactive carbon
Absorption
Distribution
Metabolism
Excretion
Healthy Volunteers

ClinicalTrials.gov processed this record on April 17, 2014