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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004001-28 | EudraCT Number |
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The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idalopirdine | Experimental | Period I: Initial administration of Lu AF67709 single dose at baseline. Period II: Administration of Lu AF67708 single dose (week 4) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [ethyl-1-14C]-idalopirdine | Drug | 120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative amounts of radioactivity excreted in urine and faeces (% of dose) | 0 to 168 hours | |
| Pharmacokinetic (PK) of idalopirdine and radioactivity in plasma (Cmax, tmax, AUC, t1/2, oral clearance and apparant volume of distribution. (composite outcome measure) | PK parameter: | 0 to 168 hours |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria do apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck | LuncbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GB802 | Leeds | United Kingdom |
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| [benzyl-7-14C]-idalopirdine | Drug | 120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose |
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