Health TrialsbyHealthPanel

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

ConditionsHealthy Volunteers (HV)Parkinson's Disease (PD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVertero Therapeutics

About this trial

This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C).

Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights.

Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit.

Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed with PD confirmed by a neurologist within a maximum of 10 years (based of year of diagnosis) prior to screening

Has current or history of GI motility dysfunction or persistent constipation

Score of < 3 on the Modified Hoehn and Yahr Scale

Is able to swallow multiple and large capsules without assistance or difficulty, in the opinion of the investigator

Disqualifiers

Has a known allergy or hypersensitivity to any component of the formulation of VT-5006 or matching placebo, or history of severe allergy or anaphylaxis to a drug, food, or other exposure

Participants taking levodopa/carbidopa or levodopa/benserazide must remain on a stable dose and regimen from at least 21 days prior to Day 1 visit to end of study (EOS) visit. Other treatments for PD symptoms may be allowed at the discretion of the medical monitor

Has any clinically significant arrhythmia(s) on ECG; specifically, the participant's corrected QT interval (QTcf) (Fridericia's correction) is >450 ms for males or >470 ms for females

Has clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants

Trial design

Design model

Parallel

Treatments tested in this trial

  • VT-5006

    Drug

    Oral Capsules, Active

  • Placebo

    Drug

    Oral Capsules, Matched Placebo

Treatment groups

84 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part A SAD ActiveExperimental treatment 1 intervention
Group B: Part A SAD PlaceboPlacebo comparator 1 intervention
Group C: Part B MAD ActiveExperimental treatment 1 intervention
Group D: Part B MAD PlaceboPlacebo comparator 1 intervention
Group E: Part C Active Low DoseExperimental treatment 1 intervention
Group F: Part C Active High DoseExperimental treatment 1 intervention
Group G: Part C PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events (AEs)

Incidence of treatment-emergent AEs (e.g. clinically significant electrocardiogram, vital signs and physical examination abnormalities; clinically significant changes on the Columbia-Suicide Severity Rating Scale \[C-SSRS\]).

Time frame
Part A: Up to 8 days; Part B: Up to 15 days; Part C: Up to 35 days;

Secondary outcomes

1

Plasma pharmacokinetic (PK) parameter: Cmax

Maximum peak plasma concentration (Cmax)

Time frame
Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
2

Plasma PK parameter: Tmax

Time to Maximum Observed Concentration (Tmax)

Time frame
Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
3

Plasma PK parameter: AUClast

Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)

Time frame
Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
4

Plasma PK parameters: AUCinf

Area under the concentration-time curve extrapolated to infinity (AUCinf)

Time frame
Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertero Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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