A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493726
• Other study ID #: ALK9072-002
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2018
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of chronic schizophrenia that is clinically stable

• Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive

• Stable antipsychotic medication regimen for >/= 2 months before Screening

• Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study

Exclusion Criteria:

• Aripiprazole used within 30 days before Screening

• History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)

• Current diagnosis of an Axis I disorder other than schizophrenia

• History of seizure disorder or any condition associated with seizures

• History of neuroleptic malignant syndrome (NMS)

• Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies

• Received medication by IM injection within 30 days before Screening

• Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening

• DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening

• Donation of blood or blood components within 4 weeks before Screening

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• ALKS 9072, Low dose
IM injection, given monthly
• ALKS 9072, Med dose
IM injection, given monthly
• ALKS 9072, High dose
IM injection, given monthly
• Placebo
Dosed matched placebo IM injection, given monthly

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Hoffman Estates	Illinois
United States	Alkermes Investigational Site	Irving	Texas
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.000000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration in plasma following last dose		4 months
Primary	Time to maximum concentration in plasma following last dose		4 months
Primary	Area under the plasma concentration time curve over the last dosing interval		4 months
Secondary	Number of Participants with Adverse Events		4 months