drugset
drugset / Trial / NCT01457339

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

NCT01457339 ↗

Phase 1 Completed 31 enrolled Shire
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2011-10-21
Primary completion
2012-01-20
Completion
2012-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Other / unclassified 50 mg Oral
Subject Lisdexamfetamine Other / unclassified 70 mg Oral
Subject Lisdexamfetamine Other / unclassified 100 mg Oral
Subject Lisdexamfetamine Other / unclassified 150 mg Oral
Subject Lisdexamfetamine Other / unclassified 200 mg Oral
Subject Lisdexamfetamine Other / unclassified 250 mg Oral

Indications

schizophrenia