Cognitive Impairment
Conditions
Keywords
Irdabisant, cognitive impairment
Brief summary
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.
Interventions
DRUGCEP-26401
CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.
DRUGdonepezil hydrochloride
Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated
DRUGmodafinil
modafinil 200 mg tablet, over-encapsulated
DRUGPlacebo
Placebos formulated to match each active drug
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject is able to give legal informed consent and understand the requirements of the study and communicate with the investigator in the local spoken language. 2. The subject is willing to comply with the study requirements (eg, all dietary, exercise, tobacco, and alcohol restrictions) and provide their written informed consent to participate in the study. 3. The subject is a man or woman, 18 to 50 years of age, inclusive. 4. The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. 5. The subject has skin type I to IV (very light to olive). 6. The subject is in a good health as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests. 7. Female subjects of childbearing potential must have a negative serum β-human chorionic gonadotropin (hCG) test (at screening) and check-in and be willing and able to use one of the protocol-specified double-barrier methods of birth control. 8. The subject is able to complete the screening process within 4 weeks prior to study drug administration.
Exclusion criteria
1. The subject has a cognitive performance outside of reference values at screening. 2. The subject smokes, is a tobacco user, currently uses nicotine products. 3. The subject has a known hypersensitivity to donepezil, modafinil, irdabisant, or one of the excipients, or has any significant food or drug allergies. 4. The subject is a female who is pregnant or lactating. 5. The subject has an intraocular pressure greater than 22 mm Hg. 6. 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. 7. The subject has a laboratory abnormality judged by the investigator as clinically significant, or measurements outside of the defined range * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rapid Visual Information Processing (RVIP) Test | Baseline to Hour 22 | — |
| Single-Choice Reaction Time | Baseline to Hour 22 | — |
| Smooth Pursuit Eye Movements | Baseline to Hour 22 | — |
| Visual Analog Scales (VAS) | Baseline to Hour 22 | Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects |
| Paired Associate Learning (PAL) 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| maximal observed plasma drug concentration (Cmax) | Baseline to Hour 22 |
| time to maximum observed plasma drug concentration (tmax) | Baseline to Hour 22 |
| Summary of participants with Adverse Events | From signing of the consent form to Day 30 |
| area under the drug concentration-time curve (AUC0-t) | Baseline to Hour 22 |
Countries
Netherlands
Outcome results
None listed