A Pilot, 4-Week, Randomized, Double-Blind, Placebo-Controlled, Inpatient, Multicenter Study of the Safety, Population Pharmacokinetics, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

Sirtsei Pharmaceuticals, Inc.2 sites in 1 country27 target enrollmentOctober 15, 2020

ConditionsSchizophrenia

InterventionsSP-624 Placebo

DrugsSP-624 Placebo

Overview

Phase: Phase 1
Intervention: SP-624
Conditions: Schizophrenia
Sponsor: Sirtsei Pharmaceuticals, Inc.
Enrollment: 27
Locations: 2
Primary Endpoint: Incidence of Adverse Events (AEs)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing acute psychosis.

Registry

clinicaltrials.gov

Start Date

October 15, 2020

End Date

April 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sirtsei Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is willing and able to provide written informed consent to participate in the study.
•Has an identified reliable informant.
•Is, in the investigator's opinion, suitable for initiating a washout from the subject's current antipsychotic regimen, if applicable, and is willing to abstain from prohibited psychotropic medications in accordance with study requirements.
•Subjects must meet screening eligibility criteria and be in an inpatient setting prior to discontinuing antipsychotic medications.
•Subject must be able, in the investigator's opinion, to safely discontinue prohibited psychotropic medications prior to Baseline without increased suicidality.
•Has a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual 5th edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders Studies.
•Is experiencing an acute exacerbation or relapse of symptoms.
•Is in generally good physical health, in the investigator's opinion, based on Screening medical history, physical examination, vital signs, and clinical laboratory values.
•Has a body mass index (BMI) between 18 and 40 kg/m2, inclusive.
•For women of reproductive potential: has a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.

Exclusion Criteria

•Is a woman who is pregnant, breastfeeding, or less than 6 months postpartum at Screening.
•Has any primary DSM-5 disorder other than schizophrenia, as confirmed by the MINI.
•Fails to discontinue prohibited psychotropic medications.
•Has, in the investigator's opinion, a significant risk of violent or destructive behavior.
•Is currently hospitalized involuntarily or incarcerated.
•Has a history or presence of any clinically significant medical condition, disease, or surgical history that could, in the investigator's opinion, jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug.
•Is, in the investigator's opinion, not a suitable candidate for the study.

Arms & Interventions

SP-624

SP-624 oral capsule, 20 mg once daily

Intervention: SP-624

Placebo

Placebo oral capsule, once daily

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time Frame: Up to 8 weeks

Secondary Outcomes

Change from Baseline in Pulse Rate (beats per minute)(Up to 4 weeks)
Number of Participants with Abnormal Clinical Laboratory Values(Up to 4 weeks)
Change from Baseline in Body Weight (kilograms)(Up to 4 weeks)
Change from Baseline in Blood Pressure (mmHg)(Up to 4 weeks)
Change from Baseline in Body Temperature (degrees celsius)(Up to 4 weeks)
Change from Baseline in ECG Heart Rate (beats per minute)(Up to 4 weeks)
Change from Baseline in ECG RR Interval (seconds)(Up to 4 weeks)
Change from Baseline in ECG PR Interval (milliseconds)(Up to 4 weeks)
Change from Baseline in ECG QTcF Interval (milliseconds)(Up to 4 weeks)
Number of Participants with Abnormal Physical Examination Findings(Up to 4 weeks)
Number of Participants with treatment-emergent suicidal ideation or behavior(Up to 5 weeks)
Number of Participants with treatment-emergent abnormal movements(Up to 4 weeks)