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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 11 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.