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The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women
Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.
For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.
All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Fasting condition in Period I | Experimental | Subjects will be in fasting condition in Period I and in a fed condition in Period II. |
|
| Group 2: Fed condition in Period I | Experimental | Subjects will be in fed condition in Period I and in fasting condition in Period II. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 | Drug | 20 mg Lu AF35700 single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability Fabs | Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose) | 0 to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours | Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700 | 0 to 120 hours |
| Cmax: maximum observed plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Leeds | United Kingdom |
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| ID | Term |
|---|---|
| C000726227 | Lu AF35700 |
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| Lu AF35700 iv | Drug | 100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose |
|
Maximum observed plasma concentration of Lu AF35700
| 0 to 120 hours |
| tmax: time at maximum observed plasma concentration | Time at which maximum observed plasma concentration of Lu AF35700 occurred | 0 to 120 hours |