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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004887-77 | EudraCT Number |
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The purpose of this study is to investigate the pharmacokinetic (PK) properties of various modified release tablet formulations of Lu AF11167 (Part A) and to investigate the pharmacokinetic (PK) properties of a modified release tablet formulation of Lu AF11167 in a fed and fasted state and following multiple dosing (Part B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Period A | Experimental | 1 reference treatment (2 mg Lu AF11167 immediate release hard capsule) + 5 different test prototype formulations of Lu AF11167 |
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| Treatment Period B | Experimental | Food interaction and multiple dosing of Lu AF11167 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF11167 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| PK parameters for Lu AF11167 estimated from the single dose treatment periods in Part A and B: Cmax, Frel, AUC0-inf, AUC0t, AUC%extr, CL/F, t½, tlag, tmax and Vz/F. | Composite analysis | 0-48 hours |
| PK parameters for Lu AF11167 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI (accumulation index), Cmax, Cpre, CL/F, t½, tmax and Vz/F. | Composite analysis | Up to 60 hours post dose on day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters for Lu AF36201 estimated from the single dose treatment periods in Part A and B: Cmax, AUC0-inf, AUC0-t, AUC%extr, t½, tlag and tmax, MR (metabolic ratio). | Composite analysis | 0-48 HOurs |
| PK parameters for Lu AF36201 estimated from the multiple dose treatment period in Part B: AUC0-tau, AI, Cmax, Cpre, MR, t½ and tmax. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Up to 70 days |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via LundbeckClinicalTrials@Lundbeck.com | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Composite analysis |
| Up to 60 hours post dose day 7 |