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

NCT04369391 | Completed Phase 1 FDA Drug

• 1 other identifier: SEP361-114
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• Placebo-adjusted change-from-baseline QTc interval (ΔΔQTc)

  24 Hours

Secondary Outcomes (7)

• Change from baseline in heart rate, QTcF, pulse rate, and QRS intervals (∆HR, ΔQTcF, ΔPR, and ∆QRS)

  24 Hours

• If a substantial heart rate (HR) effect is observed: Change from baseline in QTcS, QTcI, and QTcP (ΔQTcS, ΔQTcI, and ΔQTcP)

  24 Hours

• Placebo-adjusted change from baseline in heart rate, pulse rate, and QRS intervals (ΔΔHR, ΔΔPR, and ΔΔQRS)

  24 Hours

• If a substantial heart rate (HR) effect is observed: Placebo-adjusted ΔQTcS, and/or ΔQTcI, and/or ΔQTcP, and/or ΔQTcF (ΔΔQTcS, ΔΔQTcI, ΔΔQTcP, ΔΔQTcF) if not selected as the primary endpoint

  24 Hours

• Categorical summary for QTcF, heart rate, pulse rate, and QRS intervals

  24 Hours

Study Arms (3)

SEP363856 150 mg

EXPERIMENTAL

SEP363856 tablet 150 mg

Drug: SEP363856 150 mg

Placebo

PLACEBO COMPARATOR

matched placebo

Drug: Placebo

moxifloxacin 400 mg

ACTIVE COMPARATOR

moxifloxacin tablet 400 mg

Drug: moxifloxacin 400 mg

Interventions

SEP363856 150 mg DRUG

SEP363856 tablet 150 mg

SEP363856 150 mg

Placebo DRUG

Placebo tablet

Placebo

moxifloxacin 400 mg DRUG

moxifloxacin tablet 400 mg

moxifloxacin 400 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (7)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

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

Pico Rivera, California, 90660, United States

Location

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

San Diego, California, 92101, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Community Clinical Research Inc. Austin, TX 78754

Austin, Texas, 78754, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856; Moxifloxacin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized using a double Williams design in equal ratio to six possible sequences of receiving the three treatments being studied: SEP-363856 150mg, Matched Placebo, moxifloxacin 400mg.

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: June 18, 2020
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (7)