IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers (ADME)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01223014
First received: October 15, 2010
Last updated: February 6, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223014
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | October 15, 2010 |
| Last Updated: | February 6, 2011 |
Keywords provided by AstraZeneca:
|
Radioactive ADME Neuropathic pain |
ClinicalTrials.gov processed this record on July 26, 2017