BridgeMD
Tests treatment safety and results for Healthy Volunteers (HV)
Official title Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease
ClinicalTrials.gov ID: NCT07310264
What this study is testing
What is VT-5006?
VT-5006 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteers (hv).
Also referred to as AX-5006.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Parts A and B enroll healthy volunteers; only key entry criteria for Part C are described below.
- 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
You likely can't join if
- Has a known allergy or hypersensitivity to any component of the formulation of VT-5006 or matching placebo, or history of severe allergy or...
- 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...
- Has any clinically significant arrhythmia(s) on ECG; specifically, the participant's corrected QT interval (QTcf) (Fridericia's correction) is \>450...
- Has clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete...
- Has any of the following test results: a serum total bilirubin value \>1.5 x upper limit of normal (ULN); a serum alanine aminotransferase (ALT) or...
- Any history of lumbar surgery for any reason (e.g. herniated disc) that in the opinion of the Investigator would interfere with or pose risks to a...
See the full eligibility criteria
- Parts A and B enroll healthy volunteers; only key entry criteria for Part C are described below.
- 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
- Participants should be on a stable regimen of any prescribed (except levodopa/carbidopa, levodopa/benserazide or anticholinergic agents) or over-the-counter medications or supplements for at least 60 days prior to...
- Has suitable venous access for blood sampling
- 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...
- 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...
- Has any of the following test results: a serum total bilirubin value \>1.5 x upper limit of normal (ULN); a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value 2x ULN. As an exception...
- Any history of lumbar surgery for any reason (e.g. herniated disc) that in the opinion of the Investigator would interfere with or pose risks to a lumbar puncture procedure
- Other contraindications to having a lumbar puncture
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.