A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants

Официальное название

A Phase 1, Open-Label, Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Varegacestat Administered in Different Dose Forms in Healthy Participants

Обзор

This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting conditions.

Вмешательства

• Препарат Varegacestat Reference Formulation
  Oral administration
• Препарат Varegacestat Test Formulation
  Oral administration

Первичные конечные точки

• Evaluate the rBA of varegacestat by AUC0-t [Срок оценки: Approximately 3 weeks]
• Evaluate the rBA of varegacestat by AUC0-inf [Срок оценки: Approximately 3 weeks]
• Evaluate the rBA of varegacestat by Cmax [Срок оценки: Approximately 3 weeks]

Вторичные конечные точки (4)

• Assess the safety and tolerability of varegacestat by incidence of treatment emergent adverse events [Срок оценки: Approximately 4 weeks]
• Assess the safety and tolerability of varegacestat by incidence of laboratory abnormalities [Срок оценки: Approximately 3 weeks]
• Assess the safety and tolerability of varegacestat by incidence of changes in vital signs from baseline [Срок оценки: Approximately 3 weeks]
• Assess the safety and tolerability of varegacestat by incidence of changes from baseline of 12-lead ECG assessments [Срок оценки: Approximately 3 weeks]

Критерии участия

Критерии включения

• Healthy, adult, female of non childbearing potential or male, 18 to 55 years of age, inclusive, at the screening visit
• Male participants must follow protocol-specified contraception guidance
• Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing
• BMI ≥ 18.0 and ≤ 32.0 kg/m2 and with a body weight > 50 kg at the screening visit
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
• Able to swallow multiple capsules

Критерии исключения

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee
• History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
• History or presence of hypersensitivity or idiosyncratic reaction to varegacestat or related compounds
• History or presence of:

• Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus
• Thrombophlebitis or deep vein thrombosis
• Hematologic or coagulation disorders
• Liver disease or dysfunction; Gilbert's syndrome
• Renal dysfunction or glomerulonephritis
• Cancer (except treated basal cell carcinoma of the skin and cancer-free for 5 years, non metastatic basal or squamous cell carcinoma of the skin, and cervical carcinoma in situ)
• Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the PI or designee.

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

Другое

Центры проведения

США · 1 центр

• Celerion, Inc. — Tempe

Идентификаторы

NCT: NCT07610005 · VAR-505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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