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

March 8, 2011
July 6, 2011
May 2011
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01332903 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069
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

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: [14C] AZD5069
Single 120 mg oral dose administered on Day 1
Experimental: 1
[14C] AZD5069
Intervention: Drug: [14C] AZD5069
Not Provided

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

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.
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01332903
D3550C00013
Not Provided
AstraZeneca, Clinical Study Information
AstraZeneca
Not Provided
Principal Investigator: Prof. Tim Mant, FRCP, FFPM Quintiles Drug Research Unit at Guy's Hospital
AstraZeneca
July 2011

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