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The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF35700 oral solution (1 mg/mL) | Experimental | Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks. |
|
| Matching placebo | Placebo Comparator | Oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF35700 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG) | Screening to day 78 (up to 8 weeks after last dose) | |
| Change from baseline in AIMS, BARS and SAS Total score | Abnormal movement rating scale | Baseline to day 21 |
| Columbia Suicide Severity Rating Scale (C-SSRS) | Sceening to day 78 (up to 8 weeks after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime | Day 21 in the dosing period | |
| Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152 | Day 1 and 21 in the dosing period |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined 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 |
|---|---|---|---|---|---|---|
| PAREXEL Phase I Unit | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000726227 | Lu AF35700 |
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| Half-lives (t½) of Lu AF35700 and Lu AF36152 | Day 1 and 21 in the dosing period |
| Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen | Day 14-21 in the dosing period |