NCT01493726

A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.

Detailed description

Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	ALKS 9072, Low dose	IM injection, given monthly
DRUG	ALKS 9072, Med dose	IM injection, given monthly
DRUG	ALKS 9072, High dose	IM injection, given monthly
DRUG	Placebo	Dosed matched placebo IM injection, given monthly

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-12-16
• Last updated: 2018-08-29

Locations

6 sites across 1 country: United States