Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KarXT, Trimethobenzamide, Ondansetron, Meclizine.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers
Overview
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.
Interventions
- Drug KarXT
Specified dose on specified days - Drug Trimethobenzamide
Specified dose on specified days - Drug Ondansetron
Specified dose on specified days - Drug Meclizine
Specified dose on specified days
Primary outcome measures
- Number of participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to Day 21]
Secondary outcome measures (9)
- Number of participants with TEAEs [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]
Eligibility criteria
Inclusion criteria
- Participants must be healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
- Participants must be willing and able to be confined to an inpatient setting for a 3-week duration, follow instructions, and comply with the protocol requirements.
- Participants must have BMI ≥ 18 and ≤ 40 kg/m2.
- Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines.
Exclusion criteria
- Participants must not have history or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (\[GI\] eg, obstructive disorders \[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\], active biliary disease \[including symptomatic gallstones\]), 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.
- Participants must not have history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.
- Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- Participants must not have active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07681076 · CN012-0182