Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
NCT Number: NCT06572449
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Schizophrenia
Interventions: DRUG: KarXT
Sponsor: Karuna Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-31
Completion Date: 2025-08-08
Locations: Local Institution - 0002, Los Alamitos, California, 90720-3118, United States|Local Institution - 0004, Riverside, California, 92506-3237, United States|Local Institution - 0005, Atlanta, Georgia, 30331, United States|Local Institution - 0003, Decatur, Georgia, 30030-3440, United States|Local Institution - 0001, Marlton, New Jersey, 08053-3449, United States

Summary:
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.

Primary Outcome Measures: Incidence of treatment-emergent adverse events (TEAEs), Up to approximately 11 weeks
Secondary Outcome Measures: Incidence of TEAEs by study period, Up to approximately 11 weeks|Incidence of serious TEAEs, Up to approximately 11 weeks|Incidence of serious TEAEs by study period, Up to approximately 11 weeks|Incidence of TEAEs leading to study intervention discontinuation, Up to approximately 11 weeks|Incidence of TEAEs leading to study intervention discontinuation by study period, Up to approximately 11 weeks|Incidence of pro- and anticholinergic TEAEs, Up to approximately 11 weeks|Incidence of pro- and anticholinergic TEAEs by study period, Up to approximately 11 weeks|Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, Up to approximately 11 weeks|Change from baseline in PANSS positive score, Up to approximately 11 weeks|Change from baseline in PANSS negative score, Up to approximately 11 weeks|Change from baseline in PANSS negative Marder Factor score, Up to approximately 11 weeks|Change from baseline in Clinical Global Impression-Severity (CGI-S) score, Up to approximately 11 weeks|Spontaneously reported adverse event of special interest (AESIs), Up to approximately 11 weeks|Change from baseline in body weight, Up to approximately 11 weeks|Change from baseline in body mass index (BMI), Up to approximately 11 weeks|Change from baseline in waist circumference, 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), Up to approximately 11 weeks|Change from baseline in blood pressure, Up to approximately 11 weeks|Change from baseline in heart rate, 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., 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., Up to approximately 11 weeks|Change from baseline in clinical laboratory assessment (Urinalysis), Up to approximately 11 weeks|Change from baseline in clinical laboratory assessment (Drug screen), Up to approximately 11 weeks|Change from baseline in 12-lead ECG [Ventricular rate (bpm)], Up to approximately 11 weeks|Change from baseline in 12-lead ECG [PR interval (msec)], Up to approximately 11 weeks|Change from baseline in 12-lead ECG [QRS interval (msec)], Up to approximately 11 weeks|Change from baseline in 12-lead ECG [QT interval (msec)], Up to approximately 11 weeks|Change from baseline in 12-lead ECG [QTcF interval (msec)], 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., Up to approximately 11 weeks|Suicidal ideation scale with the use of Columbia-Suicide Severity Rating Scale (C-SSRS), Up to approximately 11 weeks