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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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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
40 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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