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 (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01284595
First received: January 26, 2011
Last updated: August 12, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01284595     History of Changes
Other Study ID Numbers: D0102C00007
Study First Received: January 26, 2011
Last Updated: August 12, 2014
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 October 23, 2014