VT-5006 for Parkinson's (NCT07310264)
Reduce constipation in Parkinson patients
- Trial ID
- NCT07310264
- Official Title
- 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.
- Goal
- Reduce constipation in Parkinson patients
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Vertero Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 84 participants
- Conditions
- Healthy Volunteers (HV), Parkinson's Disease (PD)
- Interventions
- VT-5006, Placebo
Summary For Families
The goal is to see if AX-5006 is safe and well tolerated and to collect early information on how it behaves in the body and whether it affects gut motility and Parkinson's-related biological signals in people with Parkinson's who have persistent constipation. AX-5006 is an experimental oral drug given in escalating single and multiple doses, with blood sampling and possible spinal fluid collection to track how the drug is absorbed, distributed, and cleared, and to watch for any interactions with standard PD medicines like levodopa, which must be kept at a stable dose if used. The study enrolls healthy adults and people with Parkinson's aged 18 to 80, with PD diagnosed within the past 10 years and a history of GI motility dysfunction or persistent constipation, who can swallow multiple large capsules and meet cardiac and liver safety criteria.
Locations
- Center for Human Drug Research, Leiden, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying VT-5006. The goal is to see if AX-5006 is safe and well tolerated and to collect early information on how it behaves in the body and whether it affects gut motility and Parkinson's-related biological signals in people with Parkinson's who have persistent constipation. AX-5006 is an experimental oral drug given in escalating single and multiple doses, with blood sampling and possible spinal fluid collection to track how the drug is absorbed, distributed, and cleared, and to watch for any interactions with standard PD medicines like levodopa, which must be kept at a stable dose if used. The study enrolls healthy adults and people with Parkinson's aged 18 to 80, with PD diagnosed within the past 10 years and a history of GI motility dysfunction or persistent constipation, who can swallow multiple large capsules and meet cardiac and liver safety criteria.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 7 groups, and 3 are placebo groups. Because assignment is random, you have about a 3 in 7 chance (roughly 43%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Part A: screening visit, a three-night clinic stay and a follow-up visit; a subgroup returns after approximately two weeks for another three-night stay. Part B: screening visit, seven days of daily dosing with a 10-night clinic stay and a follow-up visit. Part C: screening visit, 28 days of daily dosing with two overnight clinic stays, three clinic visits, one phone call, and a follow-up visit.