A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants

Официальное название

Phase 1, 3-Part, Open-label Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants

Обзор

The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, and to explore the effect of food after multiple doses of selected prototypes in healthy adult participants.

Вмешательства

• Препарат Xanomeline/Trospium Chloride Capsule
  Specified dose on specified days
• Препарат Xanomeline Enteric Capsule
  Specified dose on specified days
• Препарат Trospium Chloride
  Specified dose on specified days

Первичные конечные точки

• Maximum observed concentration (Cmax) [Срок оценки: Up to Day 23]
• Time of maximum observed concentration (Tmax) [Срок оценки: Up to Day 23]
• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Срок оценки: Up to Day 23]
• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Срок оценки: Up to Day 23]
• Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [Срок оценки: Up to Day 23]
• Concentration at the end of a dosing interval (Ctau) [Срок оценки: Up to Day 23]
• Apparent total body clearance (CLT/F) [Срок оценки: Up to Day 23]
• Effective elimination half-life during dosing interval (T-HALF(eff)) [Срок оценки: Up to Day 23]

Вторичные конечные точки (12)

• Number of participants with Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with Serious Adverse Events (SAEs) [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with Adverse Events of Special Interest (AESIs) [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with AEs leading to discontinuation [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with vital signs abnormalities [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with electrocardiogram (ECG) abnormalities [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with physical examination abnormalities [Срок оценки: Up to 30 days after final dose of study intervention]
• Number of participants with clinical laboratory abnormalities [Срок оценки: Up to 30 days after final dose of study intervention]
• Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to Day 25]
• Geometric mean ratio of Cmax [Срок оценки: Up to Day 23]
• Geometric mean ratio of AUC(0-T) [Срок оценки: Up to Day 23]
• Geometric mean ratio of AUC(INF) [Срок оценки: Up to Day 23]

Критерии участия

Критерии включения

• BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
• 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

Великобритания · 1 центр

• Quotient Sciences — Nottingham

Идентификаторы

NCT: NCT07063342 · CN012-0043 · U1111-1321-3511

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗