NCT01457339

Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SPD489 (Lisdexamfetamine dimesylate)	SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.
DRUG	Placebo	Placebo Capsule(s) for oral use taken once daily for 30 days

Timeline

• Start date: 2011-10-21
• Primary completion: 2012-01-20
• Completion: 2012-01-20
• First posted: 2011-10-21
• Last updated: 2021-06-03
• Results posted: 2013-01-21

Locations

2 sites across 1 country: United States