Healthy Volunteers
Conditions
Keywords
BMS-986510, KarXT, Xanomeline/Trospium, Antiemetics, Nausea, Vomiting, Gastrointestinal side effects
Brief summary
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
DRUGKarXT
Specified dose on specified days
Specified dose on specified days
DRUGOndansetron
Specified dose on specified days
DRUGMeclizine
Specified dose on specified days
Sponsors
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to Day 21 | Nausea and vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with TEAEs | Up to Day 14 | Nausea and vomiting |
| Time to first onset of nausea and vomiting | Up to Day 21 | — |
| Time to resolution of first episode of nausea or vomiting | Up to Day 21 | — |
| Number of participants with serious TEAEs | Up to Day 28 | — |
| Number of participants with Adverse Events of Special Interests (AESIs) | Up to Day 28 | — |
| Number of participants with TEAEs leading to discontinuation | Up to Day 28 | — |
| Number of participants with clinically abnormal Vital signs | Up to Day 28 | — |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 21 | — |
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed