Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GT-02287 in Parkinson's Disease (NCT06732180) | Clinical Trial Compass
RecruitingPhase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GT-02287 in Parkinson's Disease
Australia20 participantsStarted 2025-02-21
Plain-language summary
The main goal of this clinical trial is to learn about the safety and tolerability of GT-02287. The questions it aims to answer are:
* What medical problems do participants have when taking GT-02287?
* How is GT-02287 absorbed, distributed, and removed from the body of participants over time (pharmacokinetics)?
* Are there any biological effects of GT-02287 in blood and in cerebrospinal fluid that could be beneficial for people with Parkinson's disease?
Participants will:
* visit the clinic to assess if they qualify for the study (30-day Screening Period)
* if eligible, receive GT-02287 once a day every day for 90 days (90-day Open Label Treatment period)
* visit the clinic the first day of treatment, after the first 2 weeks of treatment, and every month during the 90-day Treatment Period.
* visit the clinic to assess how they are doing 14 days after the end of GT-02287 treatment (14-day Follow-Up Period).
Who can participate
Age range
30 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able and willing to provide written informed consent and be willing to comply with the requirements and restrictions of the study
* Any sex, ≥30 and ≤85 years of age
* Diagnosis of PD based on MDS criteria
* Within 7 years of PD diagnosis
* Body mass index of ≥18 and ≤40 kg/m2, and a body weight ≥45 kg and ≤120 kg
* Willing to provide a blood sample for PD-related genetic testing
* Hoehn \& Yahr 1-3, inclusive
* No severe motor fluctuations or disabling dyskinesias based on the investigator's clinical assessment
* Naïve to pharmacological treatment for PD or on stable PD medication for ≥3 months prior to Screening, including ≥4 weeks at the same dose(s) immediately before Screening
* Not pregnant or breastfeeding
* If participant is either of childbearing potential or produces potentially viable sperm, participant must agree to use 2 forms of contraception (barrier method and a second highly effective form of birth control/contraception, as defined in the protocol) if engaging in potentially reproductive intercourse (with a partner who produces potentially viable sperm or is of childbearing potential, respectively)
* Agreeing to not participate in another investigational study while taking part in this study
* For participants with known GBA1 mutations, presence of a GBA1 mutation that has been associated with an increased risk of PD
Exclusion Criteria:
* Other neurological disorders, including but not limited to Alzheimer's disease, amyotrophic later…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, nature, relationship to investigational product (IP), and severity of adverse events (AEs)
Timeframe: From first dose to Day 105
2
Incidence of clinically significant findings for clinical laboratory evaluations, physical and neurological examinations, body weight , vital signs measurements, 12-lead o 12-lead electrocardiograms (ECGs), Columbia Suicide Severity Rating Scale (C-SSRS)