Comparative Bioavailability of Risperidone.

NCT05179525 | Completed Phase 1 FDA Drug

• 1 other identifier: ROV-RISP-2020-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief Summary

This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).

Conditions

Schizophrenia

Keywords

risperidone; schizophrenia; long-acting injectable

Outcome Measures

Primary Outcomes (1)

• Area under the curve during the dosing interval (AUCtau)

  Mean steady-state area under the curve during the dosing interval for the active moiety

  28-day period following administration of the fourth dose of risperidone ISM®

Study Arms (1)

Risperidone ISM® 100 mg

EXPERIMENTAL

Subjects will receive 4 mg oral risperidone once daily for 7 days. After the 1 week oral risperidone regimen subjects will be administered 100 mg risperidone ISM as an injectable into the gluteal muscle. A total of 4 doses of intramuscular (IM) 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. Each dose will be separated by 4 weeks.

Drug: Risperidone ISM® 100 mg; Drug: Risperdal 4mg Tablet

Interventions

Risperidone ISM® 100 mg DRUG

100 mg of risperidone ISM® administered every 4 weeks

Risperidone ISM® 100 mg

Risperdal 4mg Tablet DRUG

4 mg oral risperidone once daily for 7 days

Risperidone ISM® 100 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 and \<65 years with a body mass index (BMI) of ≥17 kg/m2 but ≤35 kg/m2
• Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
• Outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable)
• Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months based on the investigator's judgement
• On oral risperidone 4 mg daily as maintenance therapy for at least the last 4 weeks prior to screening and on 4 mg oral risperidone once daily QD for at least one week prior baseline (Day1, Visit 2)
• Agrees to taper off all prohibited medications prior to baseline
• On a stable dosage of all permitted medications (with the exception of medication to be used on an as-needed basis) for at least 2 weeks prior to the baseline visit and for the duration of the study
• Clinical Global Impression - Severity (CGI-S) score of ≤4 (moderately ill)
• A female subject of childbearing potential who is sexually active and using a medically accepted contraceptive method. Acceptable methods include condoms (male or female) with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, and hormonal contraceptives. A female subject of childbearing potential who is not currently sexually active must agree that should she be so while participating in the trial, she will use a medically accepted method of contraception for the remainder of the study and for 1 month afterward. Female patients who have had a hysterectomy, bilateral tubal ligation, or bilateral salpingooophorectomy are considered surgically sterile and are thus are exempt from the requirement to use contraception. Female patients who are postmenopausal are considered not of childbearing potential and thus exempt from the contraception requirement; for the purpose of this study, postmenopausal is defined as the permanent cessation of menstruation for at least 12 months prior to screening in women ≥ 45 years of age.
• Female subjects must have a negative pregnancy test at screening (serum test) and baseline (urine test)
• Psychotherapy should not be started or changed during a patient's participation in the study. It is acceptable for a patient already receiving psychotherapy to participate in the study
• Able to speak, read, and understand sufficiently to allow completion of all study assessments
• Must provide written informed consent prior to the initiation of any protocol-specific procedures

You may not qualify if:

• Presence of an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that in the opinion of the investigator could have interfered with the interpretation of safety and PK evaluations
• Presence of a clinically significant vital sign or physical examination finding that in the opinion of the investigator could potentially interfere with the ability to evaluate safety and tolerability of the trial medication or could impair the subject's ability to complete the trial
• Presence of a clinically significant abnormality on blood or urine safety tests, which do not improve on retesting. In particular, laboratory and/or clinical evidence of clinically significant hepatic conditions, such as:
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN) and total bilirubin \> 2 × ULN; or
• ALT or AST \> 3 × ULN with the appearance of jaundice, worsening of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia
• Corrected QT interval, Fridericia's correction (QTcF) interval greater than 450 msec for males and 470 msec for females, or other clinically significant ECG abnormality on screening or baseline
• If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of trial medication, or is breastfeeding a child
• Uncontrolled or unstable diabetes, or a clinically significant abnormal Hba1c blood level
• Known or suspected (non-febrile) seizure disorder
• Known serological evidence of human immunodeficiency (HIV) antibody
• History of hepatitis B infection within the past year, or history of hepatitis C infection that has not been adequately treated and abnormal LFT values.
• History of neuroleptic malignant syndrome
• Current or past history of clinically significant tardive dyskinesia
• Primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment
• Known or suspected diagnosis of mental retardation or organic brain disorder

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (4)

Collaborative NeuroScience Research, LLC

Garden Grove, California, 92845, United States

Location

CBH Health, LLC

Gaithersburg, Maryland, 20877, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Rajinder Shiwach

DeSoto, Texas, 75115, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Tablets

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jordi Llaudó, MD

  Laboratorios Farmacéuticos Rovi

  STUDY CHAIR

Study Design

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

Model Details: This is an open-label, 1-sequence study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany) in subjects with schizophrenia who are on stable oral risperidone treatment. The study consists of a screening visit, 1 treatment period with inpatient and outpatient visits, and a follow-up visit.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: March 9, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)