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

Schizophrenia Clinical Trial

Official title:

A Phase 1, Open-Label, Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH) Risperidone When Risperidone is Administered From a Polyurethane Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774435
• Other study ID #: EN3342-102
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2013
• Last updated: October 30, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Subject Inclusion Criteria

1. Subject (and/or a subject's authorized legal representative) has provided written informed consent

2. Subject has identified a caregiver or personal contact with whom the subject has significant contact with at least once per week

3. Subject is male or female of non-child bearing potential between 18 to 60 years of age inclusive

4. Subject has a diagnosis of schizophrenia according to DSM-IV criteria

5. Subject has a body mass index (BMI) =18.5 and =35.0 kg/m2

6. Subject is assessed to be symptomatically stable by the Investigator, with regard to his or her psychiatric condition

7. 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.

8. Subject is currently stable on a 4-, 6-, or 8-mg oral dose of risperidone for 30 days prior to admission

Subject Exclusion Criteria

1. Known hypersensitivity or allergy to lidocaine or any local anesthetic agent of the amide type (local anesthetic used during implant and explant procedures)

2. Known sensitivity to polyurethane

3. Hospitalized or required acute crisis intervention for symptom exacerbation in the 30 days prior to admission as determined by the Investigator

4. 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

5. 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

6. History of abnormal scar formation or family history of keloid formation

7. 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

8. Have impaired hepatic (ALT/AST >1.5 times higher than the upper limit of normal) or renal function (eGFR <50mL/min)

9. Previously defined hypersensitivity to risperidone

10. History of neuromalignant syndrome (NMS)

11. Electroconvulsive therapy within 6 months of admission

12. Treatment of coexisting medical conditions that require the introduction of cytochrome P450 2D6 inhibitors or inducers

13. Positive screen for Hepatitis B Surface Antigen (HBsAg), Hepatitis C Antibody (anti HCV), or human immunodeficiency virus (HIV) antibody and/or antigen

14. 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

15. Prior participation in a EN3342 study

16. Involvement in the planning and/or conduct of the study (applies to both Endo staff or staff at the investigational site)

17. History of difficulty with phlebotomy procedures

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• EN3342

Locations

Country	Name	City	State
United States	CRI Lifetree	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone		6 months	Yes