Clinical trial NCT04510298: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Sirtsei Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Number of Participants with Abnormal Clinical Laboratory Values
timeFrame: Up to 4 weeks
measure: Change from Baseline in Blood Pressure (mmHg)
timeFrame: Up to 4 weeks
measure: Change from Baseline in Pulse Rate (beats per minute)
timeFrame: Up to 4 weeks
measure: Change from Baseline in Body Temperature (degrees celsius)
timeFrame: Up to 4 weeks
measure: Change from Baseline in Body Weight (kilograms)
timeFrame: Up to 4 weeks
measure: Change from Baseline in ECG Heart Rate (beats per minute)
timeFrame: Up to 4 weeks
measure: Change from Baseline in ECG RR Interval (seconds)
timeFrame: Up to 4 weeks
measure: Change from Baseline in ECG PR Interval (milliseconds)
timeFrame: Up to 4 weeks
measure: Change from Baseline in ECG QTcF Interval (milliseconds)
timeFrame: Up to 4 weeks
measure: Number of Participants with Abnormal Physical Examination Findings
timeFrame: Up to 4 weeks
measure: Number of Participants with treatment-emergent suicidal ideation or behavior
timeFrame: Up to 5 weeks
measure: Number of Participants with treatment-emergent abnormal movements
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research
state: California
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
References: