Pharmacokinetic, Safety, and Tolerability Study of Risper... | NCT01788774

ID	Type	Description	Link
2012-003303-35	EudraCT Number

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 5, 2013

First Submission Date that Met QC Criteria

Feb 7, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2023

Last Update Posted Date

Oct 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

Detailed Description

This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.

Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:

Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Risperidone ISM 50mg	Other	Three different single doses will be evaluated	Drug: Risperidone ISM 50 mg
Risperidone ISM 75mg	Other	Three different single doses will be evaluated	Drug: Risperidone ISM 75 mg
Risperidone ISM 100mg	Other	Three different single doses will be evaluated	Drug: Risperidone ISM 100 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risperidone ISM 50 mg	Drug		Risperidone ISM 50mg
Risperidone ISM 75 mg

Measure	Description	Time Frame
Area under the curve		Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of providing informed consent.
Male or female aged ≥ 18 years to < 65 years
Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
If a sexually active female of childbearing potential, using a medically accepted contraceptive method.

Exclusion Criteria:

Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
In the investigator's opinion, at imminent risk of committing self-harm
Use of depot antipsychotics within the last three months
Receipt of any investigational drugs within the last three months
Current participation in any other clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Zagreb			Croatia

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders