Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
- Registration Number
- NCT06572449
- Lead Sponsor
- Karuna Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KarXT on empty stomach and with food KarXT -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) Up to approximately 11 weeks
- Secondary Outcome Measures
Name Time Method 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 [QTcF interval (msec)] Up to approximately 11 weeks Incidence of pro- and anticholinergic TEAEs by study period Up to approximately 11 weeks Incidence of TEAEs by study period Up to approximately 11 weeks Incidence of pro- and anticholinergic TEAEs Up to approximately 11 weeks Spontaneously reported adverse event of special interest (AESIs) Up to approximately 11 weeks Change from baseline in waist circumference Up to approximately 11 weeks Change from baseline in blood pressure Up to approximately 11 weeks Change from baseline in clinical laboratory assessment (Hematology) Up to approximately 11 weeks Hematology will include full, differential blood \[red blood cell (RBC), white blood cell (WBC)\] and platelet counts, hemoglobin, hematocrit, mean corpuscular measures.
Change from baseline in clinical laboratory assessment (Clinical chemistry) Up to approximately 11 weeks Clinical chemistry will include liver and kidney function tests along with metabolic, lipids panel and electrolytes.
Change from baseline in clinical laboratory assessment (Urinalysis) Up to approximately 11 weeks Change from baseline in PANSS negative score Up to approximately 11 weeks Change from baseline in body mass index (BMI) Up to approximately 11 weeks Incidence of serious TEAEs Up to approximately 11 weeks Incidence of TEAEs leading to study intervention discontinuation by study period Up to approximately 11 weeks Incidence of TEAEs leading to study intervention discontinuation 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 Marder Factor score Up to approximately 11 weeks Change from baseline in heart rate Up to approximately 11 weeks Change from baseline in 12-lead ECG [QRS interval (msec)] Up to approximately 11 weeks Incidence of serious TEAEs by study period Up to approximately 11 weeks Change from baseline in Clinical Global Impression-Severity (CGI-S) score Up to approximately 11 weeks Change from baseline in body weight 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 Up to approximately 11 weeks BP includes systolic and diastolic measurements (mm Hg); Heart rate is measured in beats/minute (bpm)
Change from baseline in 12-lead ECG [QT interval (msec)] Up to approximately 11 weeks Change from baseline in physical examination Up to approximately 11 weeks 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.
Suicidal ideation scale with the use of Columbia-Suicide Severity Rating Scale (C-SSRS) Up to approximately 11 weeks
Trial Locations
- 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
Local Institution - 0003
🇺🇸Decatur, Georgia, United States
Local Institution - 0001
🇺🇸Marlton, New Jersey, United States