A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.

Sponsor ID
SEP361-114
Clinicaltrials.gov ID
NCT04369391
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
SEP361-114
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Jun 2020 - Nov 2020
    Healthy Volunteers
    No
    • Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent
    • Subject must give written informed consent and privacy authorization prior to participation in the study
    • Subject meets DSM-5 criteria for a primary diagnosis of schizophrenia as established by clinical interview
    • Subject must have a CGI S score ≤ 4 at Screening
    • Subject must have a PANSS total score ≤ 80 at Screening
    • Subject must have a score of ≤ 4 on the following PANSS items at Screening:
    • P7 (hostility)
    • G8 (uncooperativeness)
    • Subject must have normal to mild symptoms on all individual items of the SAS (\< 2), AIMS (\< 3) and BARS (\< 3) at Screening
    • Subject must be clinically stable for the past three months in the opinion of the Investigator
    • Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) for at least six weeks prior to Screening
    • Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, physical examination, neurological examination, vital sign measurement, electrocardiogram and clinical laboratory values
    • Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment
    • Subject tests positive for drugs of abuse or alcohol at Screening
    • Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
    • Female subject who is pregnant or lactating
    • Subject has any clinically significant abnormal laboratory value(s) at Screening as judged by the Investigator
    • Subject has an abnormal, clinically significant 12-lead ECG at screening
    • Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to first dose of study drug; has donated plasma within 72 hours prior to the first dose of study drug or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
    • Subject has an abnormal, clinically significant 12-lead ECG at screening
    • Subject has a history of sick sinus syndrome, first, second, or third-degree AV block,myocardial infarction, NYHA Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia

    Study Summary

    A clinical study to investigate the effect of an investigational drug in adults with schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart). This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 7 locations in the US. The study will last approximately 7 weeks.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: SEP363856 150 mg
    Type
    Interventional
    Masking
    Triple
    Estimated Enrollment
    150
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent
    • * Subject must give written informed consent and privacy authorization prior to participation in the study

    Exclusion Criteria

    • * Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment
    • * Subject tests positive for drugs of abuse or alcohol at Screening
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent
    • Subject must give written informed consent and privacy authorization prior to participation in the study
    • Subject meets DSM-5 criteria for a primary diagnosis of schizophrenia as established by clinical interview
    • Subject must have a CGI S score ≤ 4 at Screening
    • Subject must have a PANSS total score ≤ 80 at Screening
    • Subject must have a score of ≤ 4 on the following PANSS items at Screening:
    • P7 (hostility)
    • G8 (uncooperativeness)
    • Subject must have normal to mild symptoms on all individual items of the SAS (\< 2), AIMS (\< 3) and BARS (\< 3) at Screening
    • Subject must be clinically stable for the past three months in the opinion of the Investigator
    • Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) for at least six weeks prior to Screening
    • Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, physical examination, neurological examination, vital sign measurement, electrocardiogram and clinical laboratory values
    Exclusion Criteria:
    • Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment
    • Subject tests positive for drugs of abuse or alcohol at Screening
    • Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
    • Female subject who is pregnant or lactating
    • Subject has any clinically significant abnormal laboratory value(s) at Screening as judged by the Investigator
    • Subject has an abnormal, clinically significant 12-lead ECG at screening
    • Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to first dose of study drug; has donated plasma within 72 hours prior to the first dose of study drug or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
    • Subject has an abnormal, clinically significant 12-lead ECG at screening
    • Subject has a history of sick sinus syndrome, first, second, or third-degree AV block,myocardial infarction, NYHA Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia

    Locations

    Location
    Status
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Collaborative Neuroscience Research, LLC
    Long Beach, California, United States, 90806
    Status
    N/A
    Location
    California Neuropsychopharmacology Clinical Research Institute-LA, LLC (CNRI-LA, LLC)
    Pico Rivera, California, United States, 90660
    Status
    N/A
    Location
    California Neuropsychopharmacology Clinical Research Institute-San Diego, LLC (CNRI-SD, LLC)
    San Diego, California, United States, 92101
    Status
    N/A
    Location
    Research Centers of America, LLC
    Hollywood, Florida, United States, 33024
    Status
    N/A
    Location
    Hassman Research Institute
    Marlton, New Jersey, United States, 08053
    Status
    N/A
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