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Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers (ADME)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01147549
First received: June 11, 2010
Last updated: December 2, 2010
Last verified: December 2010
History of Changes

June 11, 2010
December 2, 2010
June 2010
July 2010   (final data collection date for primary outcome measure)
  • Percentage of radioactive dose recovered in urine and faeces and total balance [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
  • Plasma concentrations of AZD9668 [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
  • Metabolite profiling and identification in plasma and excreta [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
  • PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR ) [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01147549 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: Adverse events collected prior to treatment and after treatment including follow up. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers
An Open-Label, Single-Centre, Phase I Study to Assess the Excretion, Metabolism and Plasma Pharmacokinetics Following a Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers

The purpose of the study is to characterise the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD9668.
Not Provided
Interventional
Phase 1
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: [C14]AZD9668
Oral Solution 60 mg Single Dose
Experimental: 1
[C14]AZD9668
Intervention: Drug: [C14]AZD9668
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
July 2010
July 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 and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01147549
D0520C00016
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Chris O'Brien AstraZeneca R&D, Wilmington
Principal Investigator: Tim Mant, Professor Quintiles Drug Research Unit, United Kingdom
AstraZeneca
December 2010

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