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

NCT ID: NCT01903824

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

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.)

Group Type: EXPERIMENTAL

CEP-26401

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebos formulated to match each active drug

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.)

Group Type: EXPERIMENTAL

CEP-26401

Intervention Type: DRUG

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

donepezil hydrochloride

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebos formulated to match each active drug

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.)

Group Type: EXPERIMENTAL

CEP-26401

Intervention Type: DRUG

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

modafinil

Intervention Type: DRUG

modafinil 200 mg tablet, over-encapsulated

Placebo

Intervention Type: DRUG

Placebos formulated to match each active drug

Interventions

CEP-26401

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

Intervention Type: DRUG

donepezil hydrochloride

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

Intervention Type: DRUG

modafinil

modafinil 200 mg tablet, over-encapsulated

Intervention Type: DRUG

Placebo

Placebos formulated to match each active drug

Intervention Type: DRUG

Other Intervention Names

Irdabisant; Aricept; Provigil

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 38051

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

2013-001883-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C26401/1111

Identifier Type: -

Identifier Source: org_study_id