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
|
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Condition or disease | Intervention/treatment |
---|---|
Neuroscience | Drug: AZD2423 |
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 |
Group/Cohort | Intervention/treatment |
---|---|
1
Single cohort of 6 subjects
|
Drug: AZD2423
AZD2423
|
- 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 ]
- 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

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Ages Eligible for Study: | 50 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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)

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
United Kingdom | |
Research Site | |
London, United Kingdom |
Study Director: | Biljana Lilja | AstraZeneca | |
Principal Investigator: | Marianne Kasti | Quintiles, Inc. |
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 |