Checking the safety of the oral drug VT-5006 in adults with and without Parkinson's disease
A Phase I, Randomized, Single Ascending Dose, Multiple Ascending Dose, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AX-5006 (Aka VT-5006) in Healthy Participants and Participants With Parkinson's Disease.
This will test whether taking an oral medicine called VT-5006 is safe and tolerable for healthy adults and for adults with Parkinson's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Vertero Therapeutics Industry-sponsored |
| Locations | 1 site (Leiden) |
| Trial ID | NCT07310264 on ClinicalTrials.gov |
What this trial studies
This first-in-human, randomized, placebo-controlled Phase 1 program delivers single ascending doses to healthy volunteers (Part A), short multiple ascending daily dosing to healthy volunteers (Part B), and a 28-day dosing cohort in participants with Parkinson's disease (Part C). Parts A and B enroll healthy adults aged 18–54 with sequential cohorts receiving VT-5006 or placebo in specified ratios and inpatient clinic stays for intensive monitoring. Part C enrolls approximately 24–32 people with Parkinson's disease who have GI motility symptoms and randomizes them to high dose, low dose, or placebo for 28 days to collect safety and tolerability data. Pharmacokinetic, safety, and tolerability endpoints are collected throughout via clinic stays, blood sampling, and follow-up visits.
Who should consider this trial
Good fit: Ideal candidates are adults who are healthy volunteers aged 18–54 for Parts A/B or adults with Parkinson's disease diagnosed within 10 years who have current or past GI motility dysfunction, can swallow large capsules, and meet other stability criteria for Part C.
Not a fit: People with more advanced Parkinson's disease (Hoehn and Yahr score ≥3), those unable to swallow multiple large capsules, or those on unstable or excluded medications are unlikely to qualify or benefit from this early safety-focused study.
Why it matters
Potential benefit: If VT-5006 is safe and well tolerated, it could become an oral option to target symptoms related to GI motility in people with Parkinson's disease.
How similar studies have performed: This is a first-in-human program for VT-5006, and while other oral small-molecule approaches addressing GI symptoms in Parkinson's disease have been tested, results to date have been mixed and the agent itself is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Parts A and B enroll healthy volunteers; only key entry criteria for Part C are described below. Inclusion Criteria: * 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 enrolment in the study. Participants should not change the dosage or frequency of these medications or supplements while in the study. If changes to medications or supplements are contemplated during the study, the Investigator should be contacted prior to any change. * Has suitable venous access for blood sampling Exclusion Criteria: * 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 * 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, participants that present with elevated bilirubin in the absence of elevations in ALT or AST that fits the pattern of Gilbert's syndrome may be enrolled after discussion with the medical monitor if their conjugated bilirubin is not or slightly elevated and the level is considered to be not clinically significant. * 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
Where this trial is running
Leiden
- Center for Human Drug Research — Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: P.H.C. Kremer
- Email: clintrials@chdr.nl
- Phone: +31 0715246400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.