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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223014
First Posted: October 18, 2010
Last Update Posted: February 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Neuroscience Drug: AZD2423 Phase 1

Study Type: Observational
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Biospecimen Retention:   Samples With DNA
Pharmacogenetic samples

Estimated Enrollment: 6
Study Start Date: November 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Single cohort of 6 subjects
 Drug: AZD2423
AZD2423

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 65 Years   (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
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

Responsible Party: Marketing Company Medical Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01223014     History of Changes
Other Study ID Numbers: D2600C00008
First Submitted: October 15, 2010
First Posted: October 18, 2010
Last Update Posted: February 8, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Radioactive
ADME
Neuropathic pain


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