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
Plain-Language Summary
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.