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

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ClinicalTrials.gov Identifier: NCT01332903
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C] AZD5069 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: 1
[14C] AZD5069
Drug: [14C] AZD5069
Single 120 mg oral dose administered on Day 1




Primary Outcome Measures :
  1. 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 ]
    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)).

  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. To investigate the safety and tolerability of AZD5069 given orally [ Time Frame: From screening visit, Day 12, up to follow up visit ]
    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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01332903     History of Changes
Other Study ID Numbers: D3550C00013
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015