Clinical trial NCT01903824: Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects
Official title: A Double-Blind, Placebo- and Positive-Controlled, Randomized, Partial 6-way Crossover Study to Investigate the Pharmacodynamics and Pharmacokinetics of CEP-26401 (5, 25, and 125 μg) Following Single-Dose Administration to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Impairment
Keywords: Irdabisant
cognitive impairment
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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 exclusion criteria apply; please contact the investigator for more information.

Primary outcomes:
measure: Paired Associate Learning (PAL) Test
timeFrame: Baseline to Hour 22
measure: Rapid Visual Information Processing (RVIP) Test
timeFrame: Baseline to Hour 22
measure: Spatial Working Memory Test
timeFrame: Baseline to Hour 22
measure: Stop Signal Task (SST)
timeFrame: Baseline to Hour 22
measure: Adaptive tracking Test
timeFrame: Baseline to Hour 22
measure: Body sway Test
timeFrame: Baseline to Hour 22
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: Baseline to Hour 22
measure: Leiden Maze Test (LMT)
timeFrame: Baseline to Hour 22
measure: n-Back Working Memory Test
timeFrame: Baseline to Hour 22
measure: Polysomnography (PSG) Test
timeFrame: Baseline to Hour 22
measure: Saccadic Eye Movements
timeFrame: Baseline to Hour 22
measure: Single-Choice Reaction Time
timeFrame: Baseline to Hour 22
measure: Smooth Pursuit Eye Movements
timeFrame: Baseline to Hour 22
measure: Visual Analog Scales (VAS)
timeFrame: Baseline to Hour 22
Secondary outcomes:
measure: area under the drug concentration-time curve (AUC0-t)
timeFrame: Baseline to Hour 22
measure: maximal observed plasma drug concentration (Cmax)
timeFrame: Baseline to Hour 22
measure: time to maximum observed plasma drug concentration (tmax)
timeFrame: Baseline to Hour 22
measure: Summary of participants with Adverse Events
timeFrame: From signing of the consent form to Day 30
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Teva Investigational Site 38051
Study officials:
References: