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Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers (ADME)

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ClinicalTrials.gov Identifier: NCT01223014
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : February 8, 2011
Sponsor:
Information provided by:
AstraZeneca

October 15, 2010
October 18, 2010
February 8, 2011
November 2010
December 2010   (Final data collection date for primary outcome measure)
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 1 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 2 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 3 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 4 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 5 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 6 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 7 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 8 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 1 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 2 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 3 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 4 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 5 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 6 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 7 ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 8 ]
  • Percentage of radioactive dose recovered in urine and faeces and total percentage
  • Concentration of total radioactivity in blood and plasma
Complete list of historical versions of study NCT01223014 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination [ Time Frame: Range of Day -1 until follow up visit (Visit 3) ]
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram
  • Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination
Not Provided
Not Provided
 
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers
An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Pharmacogenetic samples
Non-Probability Sample
primary care clinic/community sample
Neuroscience
Drug: AZD2423
AZD2423
1
Single cohort of 6 subjects
Intervention: Drug: AZD2423
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
Same as current
December 2010
December 2010   (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)
  • Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

  • Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) 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
  • Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1)
  • History of alcohol abuse or excessive intake of alcohol defined as regular intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)
Sexes Eligible for Study: Male
50 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01223014
D2600C00008
No
Not Provided
Not Provided
Marketing Company Medical Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Biljana Lilja AstraZeneca
Principal Investigator: Marianne Kasti Quintiles, Inc.
AstraZeneca
February 2011