Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

NCT01774435 | Completed Phase 1

• 1 other identifier: EN3342-102
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is an study evaluating the safety, tolerability, and PK of EN3342 in implantation durations of 6 months.

Conditions

Schizophrenia

Keywords

Schizophrenia; Schizophrenic; Stable Schizophrenic

Outcome Measures

Primary Outcomes (1)

• PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone

  6 months

Study Arms (1)

EN3342

EXPERIMENTAL

EN3342 (risperidone) subcutaneous implant

Drug: EN3342

Interventions

EN3342 DRUG

EN3342

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject (and/or a subject's authorized legal representative) has provided written informed consent
• Subject has identified a caregiver or personal contact with whom the subject has significant contact with at least once per week
• Subject is male or female of non-child bearing potential between 18 to 60 years of age inclusive
• Subject has a diagnosis of schizophrenia according to DSM-IV criteria
• Subject has a body mass index (BMI) ≥18.5 and ≤35.0 kg/m2
• Subject is assessed to be symptomatically stable by the Investigator, with regard to his or her psychiatric condition
• Subject is assessed by the Investigator to be symptomatically stable with regard to pre existing medical conditions as evidenced by medical history, clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current medication regimen to control pre-existing medical and psychiatric (other than schizophrenia) conditions including the use of PRN medications.
• Subject is currently stable on a 4-, 6-, or 8-mg oral dose of risperidone for 30 days prior to admission

You may not qualify if:

• Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures)
• Known sensitivity to polyurethane
• Hospitalized or required acute crisis intervention for symptom exacerbation in the 30 days prior to admission as determined by the Investigator
• Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
• Reports or reveals a presence of clinically significant skin disorders (such as, but not limited to, skin cancer, psoriasis, eczema, or atopic dermatitis), evidence of recent sunburn, scar tissue, tattoo, open sore, body piercing or branding at the intended implantation site that would interfere with the implantation procedure or interfere with implant site assessments as determined by the Investigator
• History of abnormal scar formation or family history of keloid formation
• Have a positive screen for substances of abuse conducted at screening or had any history of abuse in the last six months as defined by DSM-IV criteria
• Have impaired hepatic (ALT/AST \>1.5 times higher than the upper limit of normal) or renal function (eGFR \<50mL/min)
• Previously defined hypersensitivity to risperidone
• History of neuromalignant syndrome (NMS)
• Electroconvulsive therapy within 6 months of admission
• Treatment of coexisting medical conditions that require the introduction of cytochrome P450 2D6 inhibitors or inducers
• Positive screen for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Antibody (anti HCV), or human immunodeficiency virus (HIV) antibody and/or antigen
• Participation in the treatment phase of a clinical study or receipt of an investigational drug within 30 days prior to study drug administration on Day 1; for investigational drugs with an elimination half-life greater than 15 days, this time period will be extended to 60 days
• Prior participation in a EN3342 study

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

CRI Lifetree

Marlton, New Jersey, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Robert Litman, MD

  CBH Health LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 24, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

US (1)