Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients

Официальное название

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study in Healthy Participants and an Expansion Cohort in Adult Patients With Multiple Sclerosis to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208

Обзор

Part 1 of this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VT7208 in healthy volunteers. Part 2 of this study will be an open-label, randomized study to characterize the effect of food on the pharmacokinetics of VT7208 in healthy volunteers. Part 3 of this study will evaluate the safety of VT7208 as monotherapy in patients with MS.

Подробное описание

This study is a Phase 1/2 randomized, double-blind, placebo-controlled, single- and multiple-dose study with staggered dose escalations in healthy volunteers.

Following completion of SAD and MAD cohorts, healthy volunteers will participate in administration of VT7208 with and without food to determine the effect of a fasted or fed state on pharmacokinetics.

Participants with MS will be recruited for part 3 of this study.

This study consists of 3 parts, as follows:

Part 1: SAD in healthy volunteers with a single dose administration of VT7208 or placebo and collection of study data.

MAD in healthy volunteers with multiple dose administration of VT7208 or placebo and collection of study data.

Part 2:

Food effect cohort in healthy volunteers. Participants will be randomized to receive open label VT7208 in either a fasted state or a fed state, and will receive the opposite at the next admission to the study site.

Part 3:

Participants MS will receive VT7208 with dose determined from Parts 1 and 2. Participation in this section will entail weekly study visits for administration of study medication and collection of study data.

Вмешательства

• Препарат VT7208
  a small synthetic molecule capsule, oral
• Препарат Placebo
  capsule, oral

Первичные конечные точки

• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose. [Срок оценки: Up to 8 days]
• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers who receive multiple daily doses. [Срок оценки: Up to 16 days]
• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of daily VT7208 in patients with MS [Срок оценки: Up to 16 weeks]

Вторичные конечные точки (12)

• Pharmacokinetics of a single dose of VT7208-Cmax [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208-T 1/2 [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208-Tmax [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208 fed state: Cmax [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208 fed state: T 1/2 [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208 fed state: Tmax [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208 fasted state: Cmax [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208 fasted state: T 1/2 [Срок оценки: up to 8 days]
• Pharmacokinetics of a single dose of VT7208 fasted state: Tmax [Срок оценки: up to 8 days]
• Pharmacokinetics of a multiple doses of VT7208-Cmax [Срок оценки: up to 16 days]
• Pharmacokinetics of a multiple doses of VT7208-T 1/2 [Срок оценки: up to 16 days]
• Pharmacokinetics of a multiple doses of VT7208-T max [Срок оценки: up to 16 days]

Критерии участия

Критерии включения

Parts 1 and 2

• Age 18-65
• Must be in good health with no significant medical history
• Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
• Able and willing to provide written informed consent

Part 3

• Age 18-60
• Must be in good health with no significant medical history
• MS diagnosis prior to Day 1 in accordance with 2017 McDonald criteria.
• Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
• Able and willing to provide written informed consent

Критерии исключения

• Evidence of clinically significant condition or disease
• Any physical or psychological condition that prohibits study completion
• Known history of illicit drug use or drug abuse, harmful alcohol use (at the -Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 7 days prior to the first dose of study agent
• History of severe allergic reactions or hypersensitivity
• Donation or loss of ≥ 1 unit of whole blood or plasma within 4 weeks prior to dosing

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

Австралия · 1 центр

• CMAX — Adelaide

Идентификаторы

NCT: NCT07085507 · VT7208-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗