Back to resultsA Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SP-624
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Collaborative Neuroscience Research
- Hassman Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SP-624
Placebo
Arm Description
SP-624 oral capsule, 20 mg once daily
Placebo oral capsule, once daily
Outcomes
Primary Outcome Measures
Incidence of Adverse Events (AEs)
Secondary Outcome Measures
Number of Participants with Abnormal Clinical Laboratory Values
chemistry, hematology, and urinalysis tests will be performed
Change from Baseline in Blood Pressure (mmHg)
Blood pressure is measured by sphygmomanometer. Change from baseline measurement will be calculated
Change from Baseline in Pulse Rate (beats per minute)
Pulse rate is measured by sphygmomanometer. Change from baseline measurement will be calculated
Change from Baseline in Body Temperature (degrees celsius)
Body temperature is measured by oral thermometer. Change from baseline measurement will be calculated
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.
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.
Change from Baseline in ECG RR Interval (seconds)
RR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Change from Baseline in ECG PR Interval (milliseconds)
PR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Change from Baseline in ECG QTcF Interval (milliseconds)
QTcF is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Number of Participants with Abnormal Physical Examination Findings
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
Number of Participants with treatment-emergent abnormal movements
Treatment-emergent abnormal movements will be assessed using a battery of movement assessments
Full Information
NCT ID
NCT04510298
First Posted
July 27, 2020
Last Updated
April 18, 2022
Sponsor
Sirtsei Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04510298
Brief Title
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirtsei Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SP-624
Arm Type
Experimental
Arm Description
SP-624 oral capsule, 20 mg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule, once daily
Intervention Type
Drug
Intervention Name(s)
SP-624
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Abnormal Clinical Laboratory Values
Description
chemistry, hematology, and urinalysis tests will be performed
Time Frame
Up to 4 weeks
Title
Change from Baseline in Blood Pressure (mmHg)
Description
Blood pressure is measured by sphygmomanometer. Change from baseline measurement will be calculated
Time Frame
Up to 4 weeks
Title
Change from Baseline in Pulse Rate (beats per minute)
Description
Pulse rate is measured by sphygmomanometer. Change from baseline measurement will be calculated
Time Frame
Up to 4 weeks
Title
Change from Baseline in Body Temperature (degrees celsius)
Description
Body temperature is measured by oral thermometer. Change from baseline measurement will be calculated
Time Frame
Up to 4 weeks
Title
Change from Baseline in Body Weight (kilograms)
Description
Body weight is measured by weight scale. Measurement is reported in kilograms. Change from Baseline measurement will be calculated.
Time Frame
Up to 4 weeks
Title
Change from Baseline in ECG Heart Rate (beats per minute)
Description
Heart rate is measured by 12-lead electrocardiogram (ECG). Change from Baseline measure will be calculated.
Time Frame
Up to 4 weeks
Title
Change from Baseline in ECG RR Interval (seconds)
Description
RR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Time Frame
Up to 4 weeks
Title
Change from Baseline in ECG PR Interval (milliseconds)
Description
PR interval is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Time Frame
Up to 4 weeks
Title
Change from Baseline in ECG QTcF Interval (milliseconds)
Description
QTcF is measured by 12-lead electrocardiogram (ECG). Change from Baseline measurement will be calculated.
Time Frame
Up to 4 weeks
Title
Number of Participants with Abnormal Physical Examination Findings
Time Frame
Up to 4 weeks
Title
Number of Participants with treatment-emergent suicidal ideation or behavior
Description
Treatment-emergent suicidal ideation and/or behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments
Time Frame
Up to 5 weeks
Title
Number of Participants with treatment-emergent abnormal movements
Description
Treatment-emergent abnormal movements will be assessed using a battery of movement assessments
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Collaborative Neuroscience Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
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