drugset / Trial / NCT01903824

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

NCT01903824

Phase 1 Completed 40 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedCrossoverDouble-blind

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.

Timeline

Start
2013-08
Primary completion
2013-10
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 10 mg
Subject IRDABISANT Small molecule 5 ug Oral
Subject IRDABISANT Small molecule 25 ug Oral
Subject IRDABISANT Small molecule 125 ug Oral
Subject Modafinil Small molecule 200 mg

Indications