Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects

Inclusion criteria

• 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.
• 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.
• The subject is a man or woman, 18 to 50 years of age, inclusive.
• The subject has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
• The subject has skin type I to IV (very light to olive).
• The subject is in a good health as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests.
• 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.
• The subject is able to complete the screening process within 4 weeks prior to study drug administration.

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

• Other exclusion criteria apply; please contact the investigator for more information.