NCT01903824

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2013-07-19
• Last updated: 2014-04-03

Locations

1 site across 1 country: Netherlands