A Study of Aripiprazole Lauroxil in Subjects With Schizop... | NCT02636842

Studies
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

NCT02636842

Sponsor

Alkermes, Inc.

Status

Completed

Last Update Posted

Jul 14, 2016Estimated

Enrollment

47Actual

Phase

Phase 1

Conditions

Schizophrenia
Schizoaffective Disorder

Interventions

Aripiprazole Lauroxil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Dec 18, 2015

First Submission Date that Met QC Criteria

Dec 21, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2016

Last Update Posted Date

Jul 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Location	Other	Deltoid or Gluteal Muscle	Drug: Aripiprazole Lauroxil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole Lauroxil	Drug	Intramuscular (IM) injection, single dose	Location

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum plasma concentration (Cmax)		Up to 7 days

Secondary Outcomes

Measure	Description	Time Frame
Time to Cmax (Tmax)		Up to 7 days
Area under the concentration-time curve from time zero to the last quantifiable time interval (AUCl0-last)		Up to 7 days
Area under the concentration-time curve from time zero to time t (AUC0-t)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a diagnosis of chronic schizophrenia or schizoaffective disorder
Has demonstrated ability to tolerate aripiprazole
Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
Additional criteria may apply

Exclusion Criteria:

Is pregnant, is planning to become pregnant, or is currently breastfeeding
Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
Is a danger to himself/herself at screening or upon admission
Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Has a positive urine drug screen at screening or Day 1
Additional criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Risinger, MD	Alkermes, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alkermes Investigational Site		Cerritos	California	90703	United States
Alkermes Investigational Site

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000603935	aripiprazole lauroxil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided