Alzheimers disease and Autism spectrum disorder Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 13/04/2026:
In Part 1, it is planned that each participant will receive a single oral dose of KarXT + KarX-EC reference on a single occasion and single oral doses of KarX +
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participants must have signed and dated a REC-approved written ICF in accordance with regulatory, local, and institutional guidelines. This ICF must be obtained before performing any protocol-related procedures. 2. Participant must be willing and able to complete all study-specific procedures and visits. 3. Healthy males and healthy females (IOCBP or INOCBP). The definition of healthy will be according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, orthostatic vital signs, single 12-lead ECG, C SSRS, and clinical laboratory tests without any clinically significant abnormalities at screening and Period 1 admission. 4. Body mass index of 18.0 kg/m² to 32.0 kg/m², inclusive, at screening. 5. Participant must be 18 to 55 years of age, inclusive, at the time of signing the ICF. 6. Female (as assigned at birth) participants must agree to follow instructions for method(s) of contraception as described in the Clinical Protocol. 7. A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described in the Clinical Protocol.
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 13/04/2026: 1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI (eg, obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis]), endocrine, immunologic, dermatologic, psychiatric, 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. Note: participants who have had basal cell cancer successfully excised at least 6 months prior to screening are permitted. 2. Participants with cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on LFT results. 3. Any significant acute or chronic medical illness (in the assessment of the investigator). 4. History or high risk of urinary retention, gastric retention, or narrow angle glaucoma or known history of prostate hypertrophy or nocturia. 5. Current or recent (within 3 months of study intervention administration) GI disease that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure). 6. Any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). 7. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months prior to screening. 8. Risk for suicidal behavior at screening as determined by the investigator’s clinical assessment and the C-SSRS scoring with an answer “Yes” to item 4 or 5 within 6 months of screening, or suicide attempt within 12 months of screening. Note: If the participant is excluded based on C-SSRS responses, the investigator must refer the participant to emergency care or mental health evaluation and intervention as appropriate per local standard of care. 9. History of ischemic or hemorrhagic stroke within 12 months prior to screening. 10. Presence of any factors that would predispose the participant to develop infection (eg, rectal fissures, poor dentition, open skin lesions). 11. Any serious acute or chronic bacterial or viral infection (eg, pneumonia, septicemia) within 3 months prior to screening. 12. History or any evidence of active infection or febrile illness within 7 days prior to first dose of study intervention (eg, bronchopulmonary, urinary, or GI). 13. History of cerebral amyloid angiopathy, epilepsy, CNS neoplasm, unstable thyroid function, or unexplained syncope. 14. History of unstable hypertension or tachycardia as evidenced by: 14.1. Blood pressure of = 160/100 mmHg at screening. 14.2. Heart rate of = 110 bpm at screening. 15. Any of the following currently or historically: 15.1. New York Heart Association Class II or greater congestive heart failure (Class II - slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain). 15.2. Grade 2 or greater angina pectoris (Grade 2 - slight limitation of ordinary activities when they are performed rapidly, after meals, in cold, in wind, under emotional stress, during the first few hours after waking up, but also walking uphill, climbing more than one flight of ordinary stairs at a normal pace and in normal
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with treatment-emergent adverse events (TEAEs) is measured using adverse event case report forms at screening, throughout treatment, and up to 30 days after final dose of study intervention 2. Number of participants with serious adverse events (SAEs) is measured using adverse event case report forms at screening, throughout treatment, and up to 30 days after final dose of study intervention 3. Number of participants with adverse events of special interest (AESIs) is measured using adverse event case report forms at screening, throughout treatment, and up to 30 days after final dose of study intervention 4. Number of participants with adverse events leading to discontinuation is measured using adverse event case report forms at screening, throughout treatment, and up to 30 days after final dose of study intervention 5. Number of participants with vital signs abnormalities is measured using vital signs assessments (blood pressure, heart rate, respiratory rate, temperature) at screening, baseline, during treatment visits, and up to 30 days after final dose of study intervention 6. Number of participants with electrocardiogram (ECG) abnormalities is measured using 12-lead ECG at screening, baseline, during treatment visits, and up to 30 days after final dose of study intervention 7. Number of participants with physical examination abnormalities is measured using structured physical examination at screening, baseline, during treatment visits, and up to 30 days after final dose of study intervention 8. Number of participants with clinical laboratory abnormalities is measured using clinical laboratory tests (hematology, biochemistry, urinalysis) at screening, baseline, during treatment visits, and up to 30 days after final dose of study intervention 9. Number of participants with Columbia-Suicide Severity Rating Scale (C-SSRS) abnormalities is measured using the Columbia-Suicide Severity Rating Scale at screening, baseline, during | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Maximum observed concentration (Cmax) is measured using plasma drug concentration assay at pre-dose and at multiple post-dose timepoints up to Day 23 2. Time of maximum observed concentration (Tmax) is measured using plasma drug concentration assay at pre-dose and at multiple post-dose timepoints up to Day 23 3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) is measured using plasma drug concentration assay at pre-dose and at multiple post-dose timepoints up to Day 23 4. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) is measured using plasma drug concentration assay at pre-dose and at multiple post-dose timepoints up to Day 23 5. Area under the concentration-time curve in one dosing interval (AUC(TAU)) is measured using plasma drug concentration assay at pre-dose and at multiple post-dose timepoints within each dosing interval up to Day 23 6. Concentration at the end of a dosing interval (Ctau) is measured using plasma drug concentration assay at the end of each dosing interval up to Day 23 7. Apparent total body clearance (CLT/F) is measured using plasma drug concentration assay and non-compartmental analysis at pre-dose and at multiple post-dose timepoints up to Day 23 8. Effective elimination half-life during dosing interval (T-HALF(eff)) is measured using plasma drug concentration assay and non-compartmental analysis at pre-dose and at multiple post-dose timepoints up to Day 23 | — |
Countries
England, United Kingdom
Contacts
Public Contact. BMS Clinical Trials Contact Center
Outcome results
None listed