Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Cognitive Impairment
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01903824
Start Date
August 1 2013
End Date
December 1 2013
Last Update
April 3 2014
Active Locations (1)
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1
Teva Investigational Site 38051
Leiden, Netherlands