Comparative Bioavailability of Risperidone

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone ISM® 100 mg

• Registration Number: NCT03527186
• Lead Sponsor: Rovi Pharmaceuticals Laboratories

Brief Summary

This is an open-label, one sequence study to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.

Detailed Description

This is an open-label, 1-sequence study in subjects 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.

Subjects who are on existing oral risperidone treatment (4 mg) will continue the oral regimen for 1 week to achieve steady-state concentrations of risperidone. Following the oral risperidone treatment, a single intramuscular (IM) dose of 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. A total of 4 IM doses will be given that will be separated by 4 weeks.

Safety assessments and pharmacokinetic (PK) sampling will be performed on each dosing day and each outpatient visit. A final follow-up visit will take place to assess each subject for safety and to obtain PK samples.

Approximately 58 subjects will be enrolled, with the intent to complete 41 subjects. Fifty-eight subjects were estimated for enrollment based on 41 completers assuming an approximate drop-out rate of 30%.

The primary objective of this study is to evaluate the steady-state comparative bioavailability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.

The secondary objective of this study is to evaluate the safety and tolerability of 100 mg risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia stabilized on oral risperidone treatment.

Study Timeline

• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Study Start: 2018-07-09
• Primary Completion: 2019-03-23
• Study Completion: 2019-04-06
• Status Verified: 2021-11
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Risperidone ISM® 100 mg	Risperidone ISM® 100 mg	A single intramuscular (IM) dose of 100 mg risperidone ISM® will be administered deeply into the gluteal muscle. A total of 4 IM doses will be given; each dose will be separated by 4 weeks

Primary Outcome Measures

Name	Time	Method
Area under the curve during the dosing interval (AUCtau)	28-day period following administration of the fourth dose of risperidone ISM®	Mean steady-state area under the curve during the dosing interval for the active moiety

Trial Locations

Locations (2)

Collaborative Neuroscience Network; 🇺🇸 Long Beach, California, United States

Hassman Research Institute; 🇺🇸 Berlin, New Jersey, United States