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

NCT04510298 | Completed Phase 1 FDA Drug

• 1 other identifier: SP-624-221
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

  Up to 8 weeks

Secondary Outcomes (12)

• Number of Participants with Abnormal Clinical Laboratory Values

  Up to 4 weeks

• Change from Baseline in Blood Pressure (mmHg)

  Up to 4 weeks

• Change from Baseline in Pulse Rate (beats per minute)

  Up to 4 weeks

• Change from Baseline in Body Temperature (degrees celsius)

  Up to 4 weeks

• Change from Baseline in Body Weight (kilograms)

  Up to 4 weeks

Study Arms (2)

SP-624

EXPERIMENTAL

SP-624 oral capsule, 20 mg once daily

Drug: SP-624

Placebo

PLACEBO COMPARATOR

Placebo oral capsule, once daily

Drug: Placebo

Interventions

SP-624 DRUG

Oral Capsule

SP-624

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirtsei Pharmaceuticals, Inc.: lead

Study Sites (2)

Collaborative Neuroscience Research

Garden Grove, California, 92845, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 12, 2020
• Study Start: October 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)