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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001883-51 | EudraCT Number |
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This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEP-26401 5 μg, 25 μg, 125 μg, placebo | Experimental | Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 in each of the dose options: 5, 25 and 125 μg, and one dose that only contains the placebos.) |
|
| CEP-26401 5 μg, 25 μg, placebo, donepezil | Experimental | Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 25 μg, and donepezil at 10mg and one dose that only contains the placebos.) |
|
| CEP-26401 5 μg, 125 μg, placebo, modafinil | Experimental | Participants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 125 μg, and modafinil at 200mg) and one dose that only contains the placebos.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEP-26401 | Drug | CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Paired Associate Learning (PAL) Test | Baseline to Hour 22 | |
| Rapid Visual Information Processing (RVIP) Test | Baseline to Hour 22 | |
| Spatial Working Memory Test | Baseline to Hour 22 | |
| Stop Signal Task (SST) | Baseline to Hour 22 | |
| Adaptive tracking Test | Baseline to Hour 22 | |
| Body sway Test | Baseline to Hour 22 | |
| Leeds Sleep Evaluation Questionnaire (LSEQ) | Baseline to Hour 22 | |
| Leiden Maze Test (LMT) | Baseline to Hour 22 | |
| n-Back Working Memory Test | Baseline to Hour 22 | |
| Polysomnography (PSG) Test | Baseline to Hour 22 | |
| Saccadic Eye Movements | Baseline to Hour 22 | |
| Single-Choice Reaction Time |
| Measure | Description | Time Frame |
|---|---|---|
| area under the drug concentration-time curve (AUC0-t) | Baseline to Hour 22 | |
| maximal observed plasma drug concentration (Cmax) | Baseline to Hour 22 | |
| time to maximum observed plasma drug concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
The subject has a cognitive performance outside of reference values at screening.
The subject smokes, is a tobacco user, currently uses nicotine products.
The subject has a known hypersensitivity to donepezil, modafinil, irdabisant, or one of the excipients, or has any significant food or drug allergies.
The subject is a female who is pregnant or lactating.
The subject has an intraocular pressure greater than 22 mm Hg.
The subject is suffering from, or has a clinically significant history of one or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or a history of any illness that, in the opinion of the investigator, might pose additional risk to the subject by participation in the study or confound the results of the study.
The subject has a laboratory abnormality judged by the investigator as clinically significant, or measurements outside of the defined range
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 38051 | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C561238 | 6-(4-(3-(2-methylpyrrolidin-1-yl)propoxy)phenyl)-2H-pyridazin-3-one |
| D000077265 | Donepezil |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| donepezil hydrochloride | Drug | Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated |
|
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| modafinil | Drug | modafinil 200 mg tablet, over-encapsulated |
|
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| Placebo | Drug | Placebos formulated to match each active drug |
|
| Baseline to Hour 22 |
| Smooth Pursuit Eye Movements | Baseline to Hour 22 |
| Visual Analog Scales (VAS) | Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects | Baseline to Hour 22 |
| Baseline to Hour 22 |
| Summary of participants with Adverse Events | From signing of the consent form to Day 30 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |