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Trial record 1 of 1 for:    irdabisant
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Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01903824
First Posted: July 19, 2013
Last Update Posted: April 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
  Purpose
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.

Condition Intervention Phase
Cognitive Impairment Drug: CEP-26401 Drug: donepezil hydrochloride Drug: modafinil Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Paired Associate Learning (PAL) Test [ Time Frame: Baseline to Hour 22 ]
  • Rapid Visual Information Processing (RVIP) Test [ Time Frame: Baseline to Hour 22 ]
  • Spatial Working Memory Test [ Time Frame: Baseline to Hour 22 ]
  • Stop Signal Task (SST) [ Time Frame: Baseline to Hour 22 ]
  • Adaptive tracking Test [ Time Frame: Baseline to Hour 22 ]
  • Body sway Test [ Time Frame: Baseline to Hour 22 ]
  • Leeds Sleep Evaluation Questionnaire (LSEQ) [ Time Frame: Baseline to Hour 22 ]
  • Leiden Maze Test (LMT) [ Time Frame: Baseline to Hour 22 ]
  • n-Back Working Memory Test [ Time Frame: Baseline to Hour 22 ]
  • Polysomnography (PSG) Test [ Time Frame: Baseline to Hour 22 ]
  • Saccadic Eye Movements [ Time Frame: Baseline to Hour 22 ]
  • Single-Choice Reaction Time [ Time Frame: Baseline to Hour 22 ]
  • Smooth Pursuit Eye Movements [ Time Frame: Baseline to Hour 22 ]
  • Visual Analog Scales (VAS) [ Time Frame: Baseline to Hour 22 ]
    Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects


Secondary Outcome Measures:
  • area under the drug concentration-time curve (AUC0-t) [ Time Frame: Baseline to Hour 22 ]
  • maximal observed plasma drug concentration (Cmax) [ Time Frame: Baseline to Hour 22 ]
  • time to maximum observed plasma drug concentration (tmax) [ Time Frame: Baseline to Hour 22 ]
  • Summary of participants with Adverse Events [ Time Frame: From signing of the consent form to Day 30 ]

Enrollment: 40
Study Start Date: August 2013
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEP-26401 5 μg, 25 μg, 125 μg, placebo
Participants 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.)
Drug: CEP-26401
CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.
Other Name: Irdabisant
Drug: Placebo
Placebos formulated to match each active drug
Experimental: CEP-26401 5 μg, 25 μg, placebo, donepezil
Participants 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.)
Drug: CEP-26401
CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.
Other Name: Irdabisant
Drug: donepezil hydrochloride
Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated
Other Name: Aricept
Drug: Placebo
Placebos formulated to match each active drug
Experimental: CEP-26401 5 μg, 125 μg, placebo, modafinil
Participants 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.)
Drug: CEP-26401
CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.
Other Name: Irdabisant
Drug: modafinil
modafinil 200 mg tablet, over-encapsulated
Other Name: Provigil
Drug: Placebo
Placebos formulated to match each active drug

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903824


Locations
Netherlands
Teva Investigational Site 38051
Leiden, Netherlands
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01903824     History of Changes
Other Study ID Numbers: C26401/1111
2013-001883-51 ( EudraCT Number )
First Submitted: July 16, 2013
First Posted: July 19, 2013
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by Teva Pharmaceutical Industries:
Irdabisant
cognitive impairment

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Donepezil
Modafinil
Armodafinil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers