NCT01096680

Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Shire · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.

Conditions

• Sleep Deprivation

Interventions

Type	Name	Description
DRUG	SPD489 20 mg	Single oral dose of 20 mg
DRUG	SPD489 50 mg	Single oral dose of 50 mg
DRUG	SPD489 70 mg	Single oral dose of 70 mg
DRUG	Armodafinil	Single oral dose of 250 mg
DRUG	Placebo	Single oral dose

Timeline

• Start date: 2010-04-05
• Primary completion: 2010-07-18
• Completion: 2010-07-18
• First posted: 2010-03-31
• Last updated: 2021-06-14
• Results posted: 2011-06-23

Locations

1 site across 1 country: United States