A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510298
• Other study ID #: SP-624-221
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2022
• Source: Sirtsei Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key 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.
• For women of reproductive potential and men with female partners of reproductive potential: agrees to remain abstinent from sexual intercourse or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug.

Key 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SP-624
Oral Capsule
• Placebo
Oral Capsule

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Research	Garden Grove	California
United States	Hassman Research Institute	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sirtsei Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 8 weeks
Secondary	Number of Participants with Abnormal Clinical Laboratory Values	chemistry, hematology, and urinalysis tests will be performed	Up to 4 weeks
Secondary	Change from Baseline in Blood Pressure (mmHg)	Blood pressure is measured by sphygmomanometer. Change from baseline measurement will be calculated	Up to 4 weeks
Secondary	Change from Baseline in Pulse Rate (beats per minute)	Pulse rate is measured by sphygmomanometer. Change from baseline measurement will be calculated	Up to 4 weeks
Secondary	Change from Baseline in Body Temperature (degrees celsius)	Body temperature is measured by oral thermometer. Change from baseline measurement will be calculated	Up to 4 weeks
Secondary	Change from Baseline in Body Weight (kilograms)	Body weight is measured by weight scale. Measurement is reported in kilograms. Change from Baseline measurement will be calculated.	Up to 4 weeks
Secondary	Change from Baseline in ECG Heart Rate (beats per minute)	Heart rate is measured by 12-lead electrocardiogram (ECG). Change from Baseline measure will be calculated.	Up to 4 weeks
Secondary	Change from Baseline in ECG RR Interval (seconds)	RR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.	Up to 4 weeks
Secondary	Change from Baseline in ECG PR Interval (milliseconds)	PR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.	Up to 4 weeks
Secondary	Change from Baseline in ECG QTcF Interval (milliseconds)	QTcF is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.	Up to 4 weeks
Secondary	Number of Participants with Abnormal Physical Examination Findings		Up to 4 weeks
Secondary	Number of Participants with treatment-emergent suicidal ideation or behavior	Treatment-emergent suicidal ideation and/or behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments	Up to 5 weeks
Secondary	Number of Participants with treatment-emergent abnormal movements	Treatment-emergent abnormal movements will be assessed using a battery of movement assessments	Up to 4 weeks