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

Official title

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

Overview

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

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

Primary outcome measures

• Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers receiving a single dose. [Time frame: 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. [Time frame: 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 [Time frame: Up to 16 weeks]

Secondary outcome measures (12)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Australia · 1 center

• CMAX — Adelaide

Identifiers

NCT: NCT07085507 · VT7208-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗