This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed. The goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
Los Alamitos, California, United States
RECRUITINGCenExel RCA - Hollywood
Hollywood, Florida, United States
RECRUITINGAtlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta, Georgia, United States
RECRUITINGiResearch Atlanta - CenExel - PPDS
Decatur, Georgia, United States
RECRUITINGNumber of participants with Treatment Emergent Adverse Events (TEAEs)
Nausea and vomiting
Time frame: Up to Day 21
Number of participants with TEAEs
Nausea and vomiting
Time frame: Up to Day 14
Time to first onset of nausea and vomiting
Time frame: Up to Day 21
Time to resolution of first episode of nausea or vomiting
Time frame: Up to Day 21
Number of participants with TEAEs
Time frame: Up to Day 28
Number of participants with serious TEAEs
Time frame: Up to Day 28
Number of participants with Adverse Events of Special Interests (AESIs)
Time frame: Up to Day 28
Number of participants with TEAEs leading to discontinuation
Time frame: Up to Day 28
Number of participants with clinically abnormal Vital signs
Time frame: Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 21
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.