A Phase 1 Study of Navlimetostat Tablet Formulations

Официальное название

A Phase 1, Open-label, Randomized, 2-Treatment, 2-Period, Crossover Study to Assess the Bioequivalence of Navlimetostat Wet-Granulation Tablet Versus the Dry-Granulation Tablet Formulation in Healthy Adult Female (as Assigned at Birth) Participants Who Are Individuals Not of Childbearing Potential

Обзор

This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female

Вмешательства

• Препарат Navlimetostat
  Specified dose on specified days

Первичные конечные точки

• Maximum Plasma Concentration (Cmax) [Срок оценки: Up to Day 17]
• Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [Срок оценки: Up to Day 17]
• Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [Срок оценки: Up to Day 17]
• Number of participants with Adverse Events (AE) [Срок оценки: Up to approximately day 37]
• Number of participants with Serious Adverse Events (AE) [Срок оценки: Up to approximately day 37]
• Number of participants with clinically significant changes in Physical Examinations (PE) [Срок оценки: Up to Day 17]
• Number of participants with clinically significant changes in vital signs (VS) [Срок оценки: Up to Day 17]
• Number of participants with clinically significant changes in 12-lead ECGs [Срок оценки: Up to Day 17]
• Number of participants with clinically significant changes in laboratory tests results [Срок оценки: Up to Day 17]

Вторичные конечные точки (5)

• Time of maximum observed drug concentration (Tmax) [Срок оценки: Up to Day 17]
• Terminal elimination half-life (T-HALF) [Срок оценки: Up to Day 17]
• Apparent total body clearance (CLT/F) [Срок оценки: Up to Day 17]
• Apparent volume of distribution during the terminal phase (Vz/F) [Срок оценки: Up to Day 17]
• Mean residence time (MRT) [Срок оценки: Up to Day 17]

Критерии участия

Критерии включения

• Participants must be healthy adult INOCBP female with no clinically significant findings on medical history, PE, VS, 12-lead ECGs, or clinical laboratory determinations, as assessed by the investigator.
• Participants must have BMI of 18.0 to 35.0 kg/m2.
• Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN.

Критерии исключения

• Participant must not have any significant acute or chronic medical illness (in the assessment of the investigator).
• Participant must not have current or recent GI disease: Any gastrointestinal disease within 3 months of study intervention administration that could possibly affect drug absorption, distribution, metabolism, and excretion (eg, bariatric procedure, history of pancreatitis, uncontrolled nausea or vomiting) in the opinion of the investigator.
• Other protocol defined inclusion/exclusion criteria applies.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• CenExel iResearch - Decatur — Decatur
• Local Institution - 0003 — Decatur
• Local Institution - 0001 — Austin
• Local Institution - 0004 — Austin

Идентификаторы

NCT: NCT07544628 · CA240-0014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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