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

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cognitive Impairment

Treatments: Drug: CEP-26401; Drug: modafinil; Drug: Placebo; Drug: donepezil hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903824

2013-001883-51 (EudraCT Number)

C26401/1111

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 3 patient groups

CEP-26401 5 μg, 25 μg, 125 μg, placebo

Experimental group

Description:

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.)

Treatment:

Drug: Placebo

Drug: CEP-26401

CEP-26401 5 μg, 25 μg, placebo, donepezil

Experimental group

Description:

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.)

Treatment:

Drug: Placebo

Drug: donepezil hydrochloride

Drug: CEP-26401

CEP-26401 5 μg, 125 μg, placebo, modafinil

Experimental group

Description:

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.)

Treatment:

Drug: Placebo

Drug: modafinil

Drug: CEP-26401