Recent Updates
Recently added Catalysts

CEP-26401

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

CEP-26401 · 1 trial · 1 indication

Phase 1 1
NCT01903824Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy SubjectsCognitive Impairment
COMPLETED40 Analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects
Cognitive ImpairmentUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about CEP-26401

What is CEP-26401 used for?

CEP-26401 is an investigational small molecule being developed for the treatment of cognitive impairment. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its potential to address cognitive deficits, though its exact mechanism of action has not been disclosed.

Who makes CEP-26401?

CEP-26401 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker symbol TEVA. The drug is currently in Phase 1 clinical development for cognitive impairment, and Teva is the sponsor of the ongoing clinical trial.

What phase is CEP-26401 in?

CEP-26401 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for cognitive impairment.

What clinical trials is CEP-26401 in?

CEP-26401 has been studied in one clinical trial, identified as NCT01903824. This was a Phase 1 study titled 'Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects,' which has been completed. The trial enrolled 40 participants and was conducted in the Netherlands.

Is CEP-26401 the same as any other drug?

No alternative names for CEP-26401 have been disclosed. The drug is known only by its developmental code name, CEP-26401, and is being investigated by Teva Pharmaceutical Industries for cognitive impairment. No other names or aliases have been associated with this compound in available information.