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Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy

NCT01677377 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-10-23

Study results available
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Summary

Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages of risperidone with clinically stable schizophrenia

Conditions

Interventions

DRUG

Risperidone

Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.

DRUG

RBP-7000

RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Philippa Whitelaw, Sr. Dir of Proj Deliver · Pharmaceutical Research Associates

  • Ashley Huston, PMP · Pharmaceutical Research Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-04-30
Completion
2013-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677377 on ClinicalTrials.gov