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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Single cohort of 6 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2423 | Drug | AZD2423 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 1 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 2 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 3 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 4 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 5 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 6 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 7 | |
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 8 | |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 1 | |
| Concentration of total radioactivity in blood and plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic/community sample
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| Name | Affiliation | Role |
|---|---|---|
| Biljana Lilja | AstraZeneca | Study Director |
| Marianne Kasti | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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Pharmacogenetic samples
| During residential period on Day 2 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 3 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 4 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 5 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 6 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 7 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 8 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Range of Day -1 until follow up visit (Visit 3) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |