Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

Официальное название

A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects

Обзор

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days.

Подробное описание

The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Additionally, VX-581 will also be administered in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA for up to ten days. Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Вмешательства

• Препарат VX-581
  Suspension for Oral Administration.
• Препарат Placebo
  Suspension for Oral Administration.
• Препарат D-IVA
  Tablet for Oral Administration.
• Препарат TEZ
  Tablet for Oral Administration.

Первичные конечные точки

• Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day -1 up to Day 8]
• Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day -1 up to Day 17]
• Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From Day -1 up to Day 17]

Вторичные конечные точки (6)

• Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581 [Срок оценки: On Day 1]
• Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post-Dose of VX-581 [Срок оценки: On Day 1]
• Part B: Maximum Observed Plasma Concentration (Cmax) of VX-581 [Срок оценки: On Days 1, 7, and 10]
• Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post-Dose of VX-581 [Срок оценки: On Days 1, 7, and 10]
• Part C: Maximum Observed Plasma Concentration (Cmax) of VX-581, TEZ (if administered), D-IVA and their Metabolite(s) [Срок оценки: On Days 1, 7, and 10]
• Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post Dose of VX-581, TEZ (if administered), D-IVA and their Metabolite(s) [Срок оценки: On Days 1, 7, and 10]

Критерии участия

Критерии включения

• Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
• A total body weight of more than (>) 50 kg
• Male and Female participants of non-childbearing potential

Критерии исключения

• History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may 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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Altasciences - Kansas City — Overland Park

Идентификаторы

NCT: NCT07283770 · VX25-581-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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