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

NCT ID: NCT04369391

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2020-11-10

Brief 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.

Detailed Description

This is a Phase 1, randomized, single-dose, active and placebo controlled, 3-period crossover study of the effect of SEP-363856 150 mg on electrocardiogram (ECG) intervals in subjects with schizophrenia. SEP-363856 and matching placebo will be utilized in a double-blind fashion. Moxifloxacin will be utilized as an active control in an open-label fashion.

The primary analysis will be based on concentration-QTc modeling of the relationship between plasma concentrations of SEP-363856 or its metabolite SEP-363854 and change-from baseline QTc.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SEP363856 150 mg

SEP363856 tablet 150 mg

Group Type: EXPERIMENTAL

SEP363856 150 mg

Intervention Type: DRUG

SEP363856 tablet 150 mg

Placebo

matched placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet

moxifloxacin 400 mg

moxifloxacin tablet 400 mg

Group Type: ACTIVE_COMPARATOR

moxifloxacin 400 mg

Intervention Type: DRUG

moxifloxacin tablet 400 mg

Interventions

SEP363856 150 mg

SEP363856 tablet 150 mg

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: DRUG

moxifloxacin 400 mg

moxifloxacin tablet 400 mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woodland International Research Group

Little Rock, Arkansas, United States

Collaborative Neuroscience Research, LLC

Long Beach, California, United States

California Neuropsychopharmacology Clinical Research Institute-LA, LLC (CNRI-LA, LLC)

Pico Rivera, California, United States

California Neuropsychopharmacology Clinical Research Institute-San Diego, LLC (CNRI-SD, LLC)

San Diego, California, United States

Research Centers of America, LLC

Hollywood, Florida, United States

Hassman Research Institute

Marlton, New Jersey, United States

Community Clinical Research Inc. Austin, TX 78754

Austin, Texas, United States

Countries

United States

Other Identifiers

SEP361-114

Identifier Type: -

Identifier Source: org_study_id