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Tests treatment safety and results for Parkinson Disease
Official title Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GT-02287 in Parkinson's Disease
ClinicalTrials.gov ID: NCT06732180
What this study is testing
What is GT-02287?
GT-02287 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85
You may be able to join if
- 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
You likely can't join if
- Other neurological disorders, including but not limited to Alzheimer's disease, amyotrophic lateral sclerosis, frontotemporal dementia, progressive...
- A history of Gaucher disease or homozygous for a GBA1 pathogenic variant known to be associated with GD or compound heterozygous for 2 alleles that...
- Known PD-associated LRRK2 pathogenic variant or other PD-associated genetic mutations other than GBA1
- Dementia or a moderate cognitive impairment (score ≥17 on the Montreal Cognitive Assessment)
- Hypersensitivity to GT-02287 or any of its excipients
- Concomitant medications metabolized primarily by cytochrome P450 3A4 (CYP3A4) that have a narrow therapeutic window, concomitant medications that are...
See the full eligibility 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...
- 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
- Other neurological disorders, including but not limited to Alzheimer's disease, amyotrophic lateral sclerosis, frontotemporal dementia, progressive supranuclear palsy, corticobasal syndrome, Huntington's disease...
- A history of Gaucher disease or homozygous for a GBA1 pathogenic variant known to be associated with GD or compound heterozygous for 2 alleles that are known to be associated with GD.
- Known PD-associated LRRK2 pathogenic variant or other PD-associated genetic mutations other than GBA1
- Dementia or a moderate cognitive impairment (score ≥17 on the Montreal Cognitive Assessment)
- Hypersensitivity to GT-02287 or any of its excipients
- Concomitant medications metabolized primarily by cytochrome P450 3A4 (CYP3A4) that have a narrow therapeutic window, concomitant medications that are substrates of breast cancer resistance protein and/or P-glycoprotein...
- Use of dopamine antagonists (antipsychotics) or anticholinergic medications
- Concomitant disease including, but not limited to cardiovascular conditions, diabetes, autoimmune disease, cancer, active infectious disease, psychotic disorders and symptoms, depressive symptoms, drug and/or alcohol...
- Malabsorption or relevant disorder which may impact the absorption of GT-02287
- Clinically significant abnormalities in laboratory test
- Contraindications to lumbar puncture (LP)
- Blood donation \>500 mL within 3 months
- Unable to comply with restrictions on food products, smoking, and /or alcohol use as defined in protocol
- participation in any treatment clinical study within 3 months or 5 half-lives, whichever is longer, prior to Screening
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Westmead, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Parkville, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Kogarah, New South Wales, Australia; Westmead, New South Wales, Australia; Woolloongabba, Queensland, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.