Multiple Sclerosis
Conditions
Keywords
pharmacokinetics, healthy volunteers, pharmacodynamics, central nervous system
Brief summary
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.
Detailed description
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.
Interventions
DRUGVT7208
a small synthetic molecule capsule, oral
DRUGPlacebo
capsule, oral
Sponsors
Vidya Therapeutics Inc
Vidya Therapeutics Australia Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose. | Up to 8 days | To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in healthy adults following a single dose. |
| 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. | Up to 16 days | To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in healthy adults following multiple daily doses. |
| Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of daily VT7208 in patients with MS | Up to 16 weeks | To assess the incidence, nature, and relationship of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients with Multiple Sclerosis (MS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of a single dose of VT7208-Cmax | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Pharmacokinetics of a single dose of VT7208-T 1/2 | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Pharmacokinetics of a single dose of VT7208-Tmax | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin. |
| Pharmacokinetics of a single dose of VT7208 fed state: Cmax | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fed state. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Pharmacokinetics of a single dose of VT7208 fed state: T 1/2 | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy adults in a fed state. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Pharmacokinetics of a single dose of VT7208 fed state: Tmax | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fed state. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin. |
| Pharmacokinetics of a single dose of VT7208 fasted state: Cmax | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fasted state. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Pharmacokinetics of a single dose of VT7208 fasted state: T 1/2 | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy adults in a fasted state. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Pharmacokinetics of a single dose of VT7208 fasted state: Tmax | up to 8 days | PK parameters of VT7208 on concentrations in plasma following a single dose in healthy volunteers in a fasted state. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin. |
| Pharmacokinetics of a multiple doses of VT7208-Cmax | up to 16 days | PK parameters of VT7208 on concentrations in plasma following multiple doses in healthy volunteers. Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Pharmacokinetics of a multiple doses of VT7208-T 1/2 | up to 16 days | PK parameters of VT7208 on concentrations in plasma following multiple doses in healthy volunteers. T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Pharmacokinetics of a multiple doses of VT7208-T max | up to 16 days | PK parameters of VT7208 on concentrations in plasma following multiple doses in healthy volunteers. Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin. |
| Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-Cmax | up to 16 weeks | PK parameters of VT7208 on concentrations in plasma in participants with Multiple Sclerosis (MS). Cmax represents the maximum (or peak) concentration of a drug in the blood plasma after it has been administered and distributed, but before the next dose |
| Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-T 1/2 | up to 16 weeks | PK parameters of VT7208 on concentrations in plasma in participants with Multiple Sclerosis (MS). T 1/2 represents the half-life of a drug, which is the time required for the concentration of a medication in the blood to decrease by exactly 50% |
| Pharmacokinetics of VT7208 in patients with Multiple Sclerosis-Tmax | up to 16 weeks | PK parameters of VT7208 on concentrations in plasma in participants with Multiple Sclerosis (MS). Tmax is the time required for a drug to reach its maximum concentration in the blood or plasma after it is administered. It is a crucial measurement used by researchers and clinicians to evaluate how quickly the body absorbs a medication and when its therapeutic effects will begin. |
| Pharmacodynamics of a single dose of VT7208 in healthy volunteers | up to 8 days | Pharmacodynamic parameters of VT7208 following a single dose in healthy volunteers. Pharmacodynamic markers are proteins that represent disease progression in MS, and will be measured by concentration of proteins within the blood. |
| Pharmacodynamics of a multiple doses of VT7208 in healthy volunteers | up to 16 days | Pharmacodynamic parameters of VT7208 following multiple doses in healthy volunteers. Pharmacodynamic markers are proteins that represent disease progression in MS, and will be measured by concentration of proteins within the blood. |
| Pharmacodynamics of VT7208 in patients with Multiple Sclerosis | up to 16 weeks | Pharmacodynamic parameters of VT7208 in participants with Multiple Sclerosis (MS). Pharmacodynamic markers are proteins that represent disease progression in MS, and will be measured by concentration of proteins within the blood. |
| Characterize the ability of VT7208 to cross the blood brain barrier in healthy volunteers following a single dose | up to 8 days | Concentration of VT7208 will be measured in cerebrospinal fluid (CSF) in healthy volunteers following a single dose.This will be measured in concentration of VT7208 within the CSF. Presence will indicate the ability of VT7208 to cross the blood/brain barrier. |
| Characterize the ability of VT7208 to cross the blood brain barrier in healthy volunteers following multiple doses | up to 16 days | Concentration of VT7208 will be measured in cerebrospinal fluid (CSF) in healthy volunteers following multiple doses.This will be measured in concentration of VT7208 within the CSF Presence will indicate the ability of VT7208 to cross the blood/brain barrier. |
| Characterize the ability of VT7208 to cross the blood brain barrier in patients with MS | up to 16 weeks | Concentration of VT7208 will be measured in cerebrospinal fluid (CSF) in patients with Multiple Sclerosis (MS). This will be measured in concentration of VT7208 within the CSF. Presence will indicate the ability of VT7208 to cross the blood/brain barrier. |
Countries
Australia
Contacts
CONTACTMIchele DeSciscio, MBSS
Outcome results
None listed