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

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903824
• Other study ID #: C26401/1111
• Secondary ID: 2013-001883-51
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2013
• Last updated: April 2, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 ß-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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment

Intervention

Drug:
• CEP-26401
CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 µg.
• donepezil hydrochloride
Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated
• modafinil
modafinil 200 mg tablet, over-encapsulated
• Placebo
Placebos formulated to match each active drug

Locations

Country	Name	City	State
Netherlands	Teva Investigational Site 38051	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired Associate Learning (PAL) Test		Baseline to Hour 22	No
Primary	Rapid Visual Information Processing (RVIP) Test		Baseline to Hour 22	No
Primary	Spatial Working Memory Test		Baseline to Hour 22	No
Primary	Stop Signal Task (SST)		Baseline to Hour 22	No
Primary	Adaptive tracking Test		Baseline to Hour 22	No
Primary	Body sway Test		Baseline to Hour 22	No
Primary	Leeds Sleep Evaluation Questionnaire (LSEQ)		Baseline to Hour 22	No
Primary	Leiden Maze Test (LMT)		Baseline to Hour 22	No
Primary	n-Back Working Memory Test		Baseline to Hour 22	No
Primary	Polysomnography (PSG) Test		Baseline to Hour 22	No
Primary	Saccadic Eye Movements		Baseline to Hour 22	No
Primary	Single-Choice Reaction Time		Baseline to Hour 22	No
Primary	Smooth Pursuit Eye Movements		Baseline to Hour 22	No
Primary	Visual Analog Scales (VAS)	Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects	Baseline to Hour 22	No
Secondary	area under the drug concentration-time curve (AUC0-t)		Baseline to Hour 22	No
Secondary	maximal observed plasma drug concentration (Cmax)		Baseline to Hour 22	No
Secondary	time to maximum observed plasma drug concentration (tmax)		Baseline to Hour 22	No
Secondary	Summary of participants with Adverse Events		From signing of the consent form to Day 30	Yes