Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers

Официальное название

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

Обзор

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.

Вмешательства

• Препарат KarXT
  Specified dose on specified days
• Препарат Trimethobenzamide
  Specified dose on specified days
• Препарат Ondansetron
  Specified dose on specified days
• Препарат Meclizine
  Specified dose on specified days

Первичные конечные точки

• Number of participants with Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to Day 21]

Вторичные конечные точки (9)

• Number of participants with TEAEs [Срок оценки: Up to Day 14]
• Time to first onset of nausea and vomiting [Срок оценки: Up to Day 21]
• Time to resolution of first episode of nausea or vomiting [Срок оценки: Up to Day 21]
• Number of participants with TEAEs [Срок оценки: Up to Day 28]
• Number of participants with serious TEAEs [Срок оценки: Up to Day 28]
• Number of participants with Adverse Events of Special Interests (AESIs) [Срок оценки: Up to Day 28]
• Number of participants with TEAEs leading to discontinuation [Срок оценки: Up to Day 28]
• Number of participants with clinically abnormal Vital signs [Срок оценки: Up to Day 28]
• Number of participants with electrocardiogram (ECG) abnormalities [Срок оценки: Up to Day 21]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07681076 · CN012-0182

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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