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

PHASE1PHASE2RECRUITING

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.

Study details:

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

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Age 18-65
  2. Must be in good health with no significant medical history
  3. Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
  4. Able and willing to provide written informed consent
  5. Age 18-60
  6. Must be in good health with no significant medical history
  7. MS diagnosis prior to Day 1 in accordance with 2017 McDonald criteria.
  8. Willing and able to attend all study visits and comply with study requirements, including lumbar puncture for CSF collection
  9. Able and willing to provide written informed consent

Exclusion criteria

  1. Evidence of clinically significant condition or disease
  2. Any physical or psychological condition that prohibits study completion
  3. 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
  4. History of severe allergic reactions or hypersensitivity
  5. Donation or loss of ≥ 1 unit of whole blood or plasma within 4 weeks prior to dosing

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT07085507

Intervention or treatment

DRUG: VT7208

DRUG: Placebo

Conditions

  • Multiple Sclerosis

  • Condition: Multiple Sclerosis

  • DRUG: VT7208 and other drugs

  • Adelaide, South Australia, Australia

  • Sponsor: Vidya Therapeutics Inc

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Research sites nearby

Closest Location:

CMAX

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  • CMAX

    Adelaide, South Australia, Australia

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Who is running the clinical trial?

VTI

Vidya Therapeutics Inc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1 SAD Cohorts: Active drug
  • Participants will receive a single dose of VT7208 in a dose escalation format.
Drug: VT7208
    PLACEBO_COMPARATOR: Part 1 SAD Cohorts: Placebo
    • Healthy volunteers will receive a single dose of placebo
    Drug: Placebo
      EXPERIMENTAL: Part 1 MAD Cohort: Active drug
      • Healthy volunteers will receive repeated doses of VT7208. Dose to be determined based on escalation data from SAD Cohorts
      Drug: VT7208
        PLACEBO_COMPARATOR: Part 1 MAD Cohort: Placebo
        • Healthy volunteers will receive repeated doses of placebo comparator.
        Drug: Placebo
          EXPERIMENTAL: Part 2: Food Effect
          • Open label randomized cohort to be administered to healthy volunteers. Participants will be randomized to receive dose in either fasted or fed state. Dose to be determined from data of SAD and MAD cohorts.
          Drug: VT7208
            EXPERIMENTAL: Part 3: Patients with Multiple Sclerosis
            • Open label cohort to be administered to patients with MS. Dose for this part will be determined from parts 1 and 2.
            Drug: VT7208

              What is the study measuring?

              Primary Outcome

              MeasureDescriptionTime Frame
              Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of VT7208 in healthy volunteers and patients with MSIncidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)Up to 16 weeks

              Secondary Outcome

              MeasureDescriptionTime Frame
              Part 1: Pharmacokinetics of a single dose of VT7208 in healthy adultsPharmacokinetic parameter of CMAX of VT7208 in the blood of healthy adultsup to 2 weeks
              Part 1: Pharmacodynamics (PD) of a single dose of VT7208 in healthy adultsBTK inhibition as measured by free, total and phosphorylated BTK level in bloodup to 2 weeks
              Part 1: Pharmacokinetics of multiple doses of VT7208 in healthy adults and in patients with MSPharmacokinetic parameter of CMAX of VT7208 in the blood of healthy adultsup to 2 weeks
              Part 1: Pharmacodynamics (PD) of multiple doses of VT7208 in healthy adults and in patients with MSBTK inhibition as measured by free, total and phosphorylated BTK level in bloodup to 2 weeks
              Part 2: Pharmacokinetics of VT7208 in healthy adults fed and fastedPharmacokinetic parameter of CMAX of VT7208 in the bloodup to 2 weeks
              Part 2: Pharmacodynamics (PD) of VT7208 in healthy adults fed and fastedBTK inhibition as measured by free, total and phosphorylated BTK level in blood of healthy adults fed and fastedup to 2 weeks
              Characterize the ability of VT7208 to cross the blood brain barrier in healthy adults and in patients with MSAbility of VT7208 to cross the blood brain barrier will be measured in cerebrospinal fluid (CSF). This will be collected during admitted study visits for healthy volunteersUp to 16 weeks
              Are you running this trial?If you're a clinic or sponsor, you can claim this study.
              Claim this trial

              References

              Clinical Trials Gov: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VT7208 in Healthy Participants and MS Patients

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