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Cognitive ImpairmentPhase 1NCT01903824

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

A Phase 1 study testing CEP-26401, donepezil hydrochloride and modafinil in people with Cognitive Impairment, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Impairment
What is being tested?
CEP-26401, donepezil hydrochloride and modafinil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteNetherlands
Study dates
Aug 2013to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Teva Investigational Site 38051

    Leiden

Other trials in Netherlands

About this study

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

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.

Being tested
CEP-26401, donepezil hydrochloride, modafinil, Placebo
Keywords
Irdabisant, cognitive impairment
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CEP-26401Drug

    Also called Irdabisant

    CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.

  • donepezil hydrochlorideDrug

    Also called Aricept

    Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated

  • modafinilDrug

    Also called Provigil

    modafinil 200 mg tablet, over-encapsulated

  • PlaceboDrug

    Placebos formulated to match each active drug

Study groups in NCT01903824
Study groupRoleWhat they receive
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.)
Receives: Drug: CEP-26401; Drug: Placebo
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.)
Receives: Drug: CEP-26401; Drug: donepezil hydrochloride; Drug: Placebo
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.)
Receives: Drug: CEP-26401; Drug: modafinil; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paired Associate Learning (PAL) Test

    Measured: Baseline to Hour 22

  2. Rapid Visual Information Processing (RVIP) Test

    Measured: Baseline to Hour 22

  3. Spatial Working Memory Test

    Measured: Baseline to Hour 22

  4. Stop Signal Task (SST)

    Measured: Baseline to Hour 22

  5. Adaptive tracking Test

    Measured: Baseline to Hour 22

  6. Body sway Test

    Measured: Baseline to Hour 22

  7. Leeds Sleep Evaluation Questionnaire (LSEQ)

    Measured: Baseline to Hour 22

  8. Leiden Maze Test (LMT)

    Measured: Baseline to Hour 22

  9. n-Back Working Memory Test

    Measured: Baseline to Hour 22

  10. Polysomnography (PSG) Test

    Measured: Baseline to Hour 22

  11. Saccadic Eye Movements

    Measured: Baseline to Hour 22

  12. Single-Choice Reaction Time

    Measured: Baseline to Hour 22

  13. Smooth Pursuit Eye Movements

    Measured: Baseline to Hour 22

  14. Visual Analog Scales (VAS)

    Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects

    Measured: Baseline to Hour 22

Secondary outcomes (4)

  1. area under the drug concentration-time curve (AUC0-t)

    Measured: Baseline to Hour 22

  2. maximal observed plasma drug concentration (Cmax)

    Measured: Baseline to Hour 22

  3. time to maximum observed plasma drug concentration (tmax)

    Measured: Baseline to Hour 22

  4. Summary of participants with Adverse Events

    Measured: From signing of the consent form to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903824
Sponsor's protocol ID
C26401/1111
Other IDs
2013-001883-51
Status last verified
Apr 2014
First submitted
16 Jul 2013
Last updated
3 Apr 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CEP-26401, donepezil hydrochloride and modafinil in people with Cognitive Impairment, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paired Associate Learning (PAL) Test (time frame: Baseline to Hour 22). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01903824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.

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