Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia

Karuna Therapeutics, Inc., a Bristol Myers Squibb company173 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

173

Conditions

Schizophrenia

Interventions

KarXTDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) for Schizophrenia and Psychotic Disorder Studies version 7.0.2. * Positive and Negative Syndrome Scale (PANSS) total score of ≤ 80 at screening and Baseline. * Clinical Global Impression-Severity (CGI-S) score of ≤ 4 at screening and Baseline. * Willing and able to discontinue all antipsychotic medications prior to baseline visit. Exclusion Criteria: * History or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * Any primary DSM-5 disorder other than schizophrenia within 12 months before screening. * History of treatment resistance to schizophrenia medications. * History of allergy/hypersensitivity to KarXT. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (6)

Local Institution - 0002

Los Alamitos, California, United States

Local Institution - 0004

Riverside, California, United States

Local Institution - 0006

Hollywood, Florida, United States

Local Institution - 0005

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time frame: Up to approximately 11 weeks

Secondary Outcomes

Incidence of TEAEs by study period

Time frame: Up to approximately 11 weeks

Incidence of serious TEAEs

Time frame: Up to approximately 11 weeks

Incidence of serious TEAEs by study period

Time frame: Up to approximately 11 weeks

Incidence of TEAEs leading to study intervention discontinuation

Time frame: Up to approximately 11 weeks

Incidence of TEAEs leading to study intervention discontinuation by study period

Time frame: Up to approximately 11 weeks

Incidence of pro- and anticholinergic TEAEs

Time frame: Up to approximately 11 weeks

Incidence of pro- and anticholinergic TEAEs by study period

Time frame: Up to approximately 11 weeks

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Time frame: Up to approximately 11 weeks

Change from baseline in PANSS positive score

Time frame: Up to approximately 11 weeks

Change from baseline in PANSS negative score

Time frame: Up to approximately 11 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Local Institution - 0003

Decatur, Georgia, United States

Local Institution - 0001

Marlton, New Jersey, United States

Change from baseline in PANSS negative Marder Factor score

Time frame: Up to approximately 11 weeks

Change from baseline in Clinical Global Impression-Severity (CGI-S) score

Time frame: Up to approximately 11 weeks

Spontaneously reported adverse event of special interest (AESIs)

Time frame: Up to approximately 11 weeks

Change from baseline in body weight

Time frame: Up to approximately 11 weeks

Change from baseline in body mass index (BMI)

Time frame: Up to approximately 11 weeks

Change from baseline in waist circumference

Time frame: Up to approximately 11 weeks

Change from baseline in orthostatic vital signs (supine and standing after 2 minutes) at Day 7 and Day 14: blood pressure (systolic and diastolic) and heart rate

BP includes systolic and diastolic measurements (mm Hg); Heart rate is measured in beats/minute (bpm)

Time frame: Up to approximately 11 weeks

Change from baseline in blood pressure

Time frame: Up to approximately 11 weeks

Change from baseline in heart rate

Time frame: Up to approximately 11 weeks

Change from baseline in clinical laboratory assessment (Hematology)

Hematology will include full, differential blood \[red blood cell (RBC), white blood cell (WBC)\] and platelet counts, hemoglobin, hematocrit, mean corpuscular measures.

Time frame: Up to approximately 11 weeks

Change from baseline in clinical laboratory assessment (Clinical chemistry)

Clinical chemistry will include liver and kidney function tests along with metabolic, lipids panel and electrolytes.

Time frame: Up to approximately 11 weeks

Change from baseline in clinical laboratory assessment (Urinalysis)

Time frame: Up to approximately 11 weeks

Change from baseline in clinical laboratory assessment (Drug screen)

Time frame: Up to approximately 11 weeks

Change from baseline in 12-lead ECG [Ventricular rate (bpm)]

Time frame: Up to approximately 11 weeks

Change from baseline in 12-lead ECG [PR interval (msec)]

Time frame: Up to approximately 11 weeks

Change from baseline in 12-lead ECG [QRS interval (msec)]

Time frame: Up to approximately 11 weeks

Change from baseline in 12-lead ECG [QT interval (msec)]

Time frame: Up to approximately 11 weeks

Change from baseline in 12-lead ECG [QTcF interval (msec)]

Time frame: Up to approximately 11 weeks

Change from baseline in physical examination

A complete (body temperature, general appearance, head/eyes/ears/nose/throat, examination of thorax and abdomen, assessment of cardiac, musculoskeletal, and circulatory systems, palpations for lymphadenopathy, and limited neurological examination) and targeted organ systems physical examinations will be performed.

Time frame: Up to approximately 11 weeks

Suicidal ideation scale with the use of Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame: Up to approximately 11 weeks