Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01332903
First received: March 8, 2011
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of [14C] AZD5069.


Condition Intervention Phase
Healthy
Drug: [14C] AZD5069
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood [ Time Frame: From pre-dose until 168 hours post last dose ] [ Designated as safety issue: No ]
    To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).

  • To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax). [ Time Frame: From pre-dose until 168hours post last dose ] [ Designated as safety issue: No ]
  • To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance. [ Time Frame: From pre-dose until 168hours post last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of AZD5069 given orally [ Time Frame: From screening visit, Day 12, up to follow up visit ] [ Designated as safety issue: Yes ]
    Assessments will include adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis and physical examination. Absolute values and change in baseline for any of these parameters will be reported.


Estimated Enrollment: 6
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
[14C] AZD5069
Drug: [14C] AZD5069
Single 120 mg oral dose administered on Day 1

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a body mass index (BMI) of ≥18 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-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
  • Healthy Male volunteers aged 50 and over

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 last 5 years
  • History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
  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: NCT01332903

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof. Tim Mant, FRCP, FFPM Quintiles Drug Research Unit at Guy's Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca, Clinical Study Information
ClinicalTrials.gov Identifier: NCT01332903     History of Changes
Other Study ID Numbers: D3550C00013
Study First Received: March 8, 2011
Last Updated: July 6, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
UK: Research Ethics Committee

ClinicalTrials.gov processed this record on July 23, 2014