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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Neuroscience Drug: AZD2423

Study Design
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Study Type : Observational
Estimated Enrollment : 6 participants
Time Perspective: Prospective
Official Title: 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
Study Start Date : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010
Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Single cohort of 6 subjects
 Drug: AZD2423
AZD2423


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 1 ]
  2. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 2 ]
  3. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 3 ]
  4. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 4 ]
  5. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 5 ]
  6. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 6 ]
  7. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 7 ]
  8. Percentage of radioactive dose recovered in urine and faeces and total percentage [ Time Frame: During residential period on Day 8 ]
  9. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 1 ]
  10. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 2 ]
  11. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 3 ]
  12. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 4 ]
  13. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 5 ]
  14. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 6 ]
  15. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 7 ]
  16. Concentration of total radioactivity in blood and plasma [ Time Frame: During residential period on Day 8 ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]

Biospecimen Retention:   Samples With DNA
Pharmacogenetic samples

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic/community sample
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)
  • 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)
Contacts and Locations
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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): NCT01223014


Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Biljana Lilja AstraZeneca
Principal Investigator: Marianne Kasti Quintiles, Inc.
More Information
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Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01223014     History of Changes
Other Study ID Numbers: D2600C00008
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Radioactive
ADME
Neuropathic pain