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Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers (ADME)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01058447
First received: January 26, 2010
Last updated: November 17, 2010
Last verified: November 2010

January 26, 2010
November 17, 2010
February 2010
March 2010   (final data collection date for primary outcome measure)
Pharmacokinetic variables and Radioactivity [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058447 on ClinicalTrials.gov Archive Site
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981

Not Provided
Interventional
Phase 1
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: AZD1981
Oral tablet, 250 mg, single dose
Experimental: 1
Intervention: Drug: AZD1981
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedure
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

  • Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
  • History or presence of any clinically significant disease or disorder in the opinion of the investigator
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
Male
50 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01058447
D9830C00006
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Eva S Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Tim Mant, Professor Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom
AstraZeneca
November 2010

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