First in Man Study of Safety, Tolerability and PK Profile of RBP-7000

Schizophrenia Clinical Trial

Official title: An Open Label, Single Center, Single Dose, Phase 1, First in Man Study of the Safety, Tolerability and Pharmacokinetic Profile of RBP-7000

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and PK profile of a single dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than risperidone.

Clinical Trial Description

Twelve subjects with stable schizophrenia will be enrolled. The expected duration of participation is 88 days which includes at least a 2 days screening and an 85 day treatment period (15 -day inpatient stay in the clinical unit and an additional 70-day outpatient period, including the Day 85 end of study follow up or early termination visit. Visits will occur approximately weekly during the outpatient period.

Neurological and clinical symptom assessments (Positive and Negative Syndrome Scale [PANSS], Clinical Global Impressions-Schizophrenic Specific [CGI-SCH], Simpson-Angus Scale [SAS], Barnes Akathisia Scale [BAS], and Columbia-Suicide Severity Rating Scale [C-SSRS]) will be conducted at screening, on the day of admission to the clinical unit (Day -1), and at each post-dose visit throughout the study including the follow-up visit. Scale results will be reviewed by the Principal Investigator. The Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia will be performed at screening and at each post-dose visit throughout the study including the end of study follow-up visit. CYP-2D6 genotyping will be conducted at screening. Tolerability will be measured using SAS, which will be conducted as described above.

Blood samples to assess the PK parameters will be taken from pre-dose until approximately 84 days post-dose.

End of study procedures will be conducted on follow-up Day 85 (84 days post-dose) or early termination (ET) to assess any adverse events (AEs) that were ongoing at the last visit, any new AEs that have developed, and for measurement of safety parameters. ;

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT02765555
• Study type: Interventional
• Source: Indivior Inc.
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Completion date: September 2010