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CEP-26401

Phase 1

Cognitive Impairment | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Apr 3, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01903824Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy SubjectsPHASE1 COMPLETED 40 — — Aug 1, 2013Dec 1, 2013Apr 3, 20141 Netherlands
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Study Endpoints
Primary Endpoints
Paired Associate Learning (PAL) Test
Baseline to Hour 22
Rapid Visual Information Processing (RVIP) 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
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

Secondary Endpoints
area under the drug concentration-time curve (AUC0-t)
Baseline to Hour 22
maximal observed plasma drug concentration (Cmax)
Baseline to Hour 22
time to maximum observed plasma drug concentration (tmax)
Baseline to Hour 22
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
CEP-26401 5 μg, 25 μg, 125 μg, placeboEXPERIMENTALParticipants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 in each of the dose options: 5, 25 and 125 μg, and one dose that only contains the placebos.)
CEP-26401 5 μg, 25 μg, placebo, donepezilEXPERIMENTALParticipants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 25 μg, and donepezil at 10mg and one dose that only contains the placebos.)
CEP-26401 5 μg, 125 μg, placebo, modafinilEXPERIMENTALParticipants are dosed four times during this cross-over study. This group takes three active interventions (CEP-26401 at 5 and 125 μg, and modafinil at 200mg) and one dose that only contains the placebos.)
Interventions
NameTypeDescription
CEP-26401DRUGCEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.
donepezil hydrochlorideDRUGDonepezil hydrochloride, two 5 mg tablets, each over-encapsulated
modafinilDRUGmodafinil 200 mg tablet, over-encapsulated
PlaceboDRUGPlacebos formulated to match each active drug
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Netherlands
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