Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudractCT No: 2008-006129-14 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2066 | Drug | 1 dose oral solution |
| Measure | Description | Time Frame |
|---|---|---|
| Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066 | Until >90% of predicted total radioactivity has been recovered | |
| Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma | Sampling at defined timepoints during residential period from pre-dose until 168h post-dose. | |
| Metabolite profile in plasma and excreta | Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| AZD2066 metabolites in plasma+excreta if feasable | Sampling at defined timepoints during residential period from pre-dose until 48h post-dose. | |
| Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emeline Ramos, MD | AstraZeneca R&D, CPU Alderley Park, UK | Principal Investigator |
| Lars Ståhle, MD | AstraZeneca R&D, Södertälje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cheshire | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C587779 | AZD2066 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3. |