Phase 1 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Parts 1, 2, and 4 (healthy volunteer sections):

• People aged 18 to 55 years who are in general good health (Parts 1 and 2 include both men and women; Part 4 details to be confirmed with trial site)
• Women of childbearing potential with a negative pregnancy test at screening (Parts 1 and 2 only)
• Women who are post-menopausal, confirmed by a specific hormone blood test at screening (Parts 1 and 2 only)
• Men, and men whose partners could become pregnant, who are willing to use a highly effective form of contraception
• People with a body weight of at least 50 kg and a body mass index (BMI) between 18 and 32
• People with no significant history of allergic reaction to the study drug (MTX325) or its ingredients
• People with normal blood test results for kidney, liver, and blood cell function
• People who test negative for drugs of abuse and alcohol within the required timeframe before the first dose
• People who test negative for HIV, hepatitis B, and hepatitis C at screening
• People with a normal heart tracing (ECG) and normal vital signs (such as blood pressure and heart rate)
• People who are available to attend all study visits, including follow-up appointments
• People who the study doctor considers fit to take part
• People who provide written agreement to participate in the study
• People who test negative for COVID-19 on the day they are admitted to the study site (if required)
• Part 4 only: People with a normal MRI scan performed within 3 months before receiving the study drug

Part 3 (older healthy volunteers):

• People aged 65 years or older who are in general good health (both men and women)
• Women who are post-menopausal, confirmed by a specific hormone blood test at screening
• Men, and men whose partners could become pregnant, who are willing to use a highly effective form of contraception
• People with a body weight of at least 50 kg and a BMI between 18 and 32
• People with no significant history of allergic reaction to the study drug or its ingredients
• People with normal blood, urine, and biochemistry test results
• People with adequate kidney function, confirmed by a specific blood test at screening
• People who test negative for drugs of abuse, HIV, hepatitis B, and hepatitis C at screening
• People with a normal heart tracing (ECG) and normal vital signs
• People who are available to attend all study visits including follow-up
• People who the study doctor considers fit to take part
• People who provide written agreement to participate
• People who test negative for COVID-19 on admission

Part 5 (Parkinson's disease section):

• People aged 40 to 75 years, both men and women
• Women of childbearing potential who are willing to use highly effective contraception
• People with a BMI between 18 and 34
• People already taking a stable dose of a certain type of antidepressant (SSRIs) for at least 60 days before the study and who can remain on that same dose throughout
• People in whom other causes of Parkinson's-like symptoms have been ruled out
• People with no significant history of allergic reaction to the study drug or its ingredients
• People who test negative for drugs of abuse (excluding alcohol) at screening
• People who test negative for HIV, hepatitis B, and hepatitis C at screening
• People with no history of a specific dangerous heart rhythm condition (torsade de pointes), long QT syndrome, heart failure, low potassium, or other significant heart risk factors
• People with normal vital signs during the screening period
• People able to complete all study assessments and attend all visits
• People willing and able to provide written agreement to participate
• People with a confirmed Parkinson's disease diagnosis according to recognised medical criteria (MDS Criteria)
• People without dementia, as confirmed by a standard memory and thinking assessment (MoCA) at baseline

Who may not be able to join:

Parts 1, 2, and 4:

• People with a significant history of stomach or bowel problems that could affect how the study drug is absorbed
• People currently taking prescription or non-prescription medicines that are not permitted under the study rules
• People who have reported serious thoughts of suicide (as assessed by a standard rating scale; Part 2 only)
• People with significant problems affecting the kidneys, liver, brain or nervous system, breathing, heart, or metabolism
• People with a significant history of drug or alcohol misuse (defined as drinking more than 14 units of alcohol per week)
• People who are unable to communicate effectively with the study team
• People who have taken part in a study of a new medicine within the previous 3 months or within five half-lives of that medicine, whichever is longer
• People who have donated 450 mL or more of blood in the 3 months before the first study dose
• People who are vegan, vegetarian, or follow other dietary restrictions (Part 1 food effect evaluation only)
• People who use nicotine products (such as cigarettes, patches, or vapes)
• People with very high daily caffeine intake
• Women who are pregnant, breastfeeding, or currently lactating (Parts 1 and 2 only)
• People with veins that are not suitable for blood tests or cannulas
• People with a recent COVID-19 infection whose symptoms have not fully resolved
• People who have received a COVID-19 vaccine injection within the restricted period before the first dose

Parts 1 and 2 — spinal fluid sampling group only:

• People for whom a lumbar puncture (spinal tap) would not be medically appropriate
• People with a significant history of allergic reaction to local anaesthetic
• People with a significant history of major back or lumbar spine surgery

Part 4 only:

• People who have previously been exposed to ionising radiation in research studies, if the combined exposure would exceed 10 mSv over the previous 12 months
• People for whom inserting an arterial line (a small tube into an artery) would not be safe
• People who are unable to lie still and flat for up to 120 minutes for PET scan procedures
• People for whom an MRI scan would not be safe
• People who experience claustrophobia (fear of enclosed spaces) or needle phobia
• People with any history of allergies or atopy (a tendency to develop allergic conditions)
• People with a current or past history of an abnormally high level of a certain type of white blood cell (eosinophilia) where the cause is unknown or ongoing
• People with a history of a specific severe skin condition called Erythema Multiforme, or with identified risk factors for it

Part 3 only:

• People with a significant history of stomach or bowel problems likely to affect drug absorption
• People with signs of a fever or illness within one week of the first dose
• People taking prescription or non-prescription medicines, vitamins, herbal supplements, or any medicine known to affect heart rhythm, within 35 days or 5 half-lives before the first dose
• People with significant problems affecting the kidneys, liver, brain or nervous system, breathing, heart, or metabolism
• People with a history of a specific dangerous heart rhythm (torsade de pointes), heart failure, low potassium, long QT syndrome, or other significant heart risk factors
• People with a significant history of drug or alcohol misuse
• People with very high daily caffeine intake
• People who cannot communicate effectively with the study team
• People who have taken part in a study of a new medicine within the previous 3 months or five half-lives
• People who have donated 450 mL or more of blood in the 3 months before the first study dose
• People who have received a COVID-19 vaccine within 35 days before the first dose
• People who use nicotine products
• People with veins not suitable for blood tests or cannulas
• People with a recent COVID-19 infection whose symptoms have not fully resolved

Part 5 only:

• People with significant stomach or bowel conditions, or other major medical conditions, that could affect drug absorption or participant safety, or interfere with study results
• People with a significant neurological condition other than Parkinson's disease, including a stroke in the past 12 months, a seizure in the past 5 years, or a head injury with loss of consciousness in the past 6 months
• People with known Parkinson's disease risk genes noted in their medical history
• People who currently live in a nursing home or assisted care facility
• People who have had more than 2 Parkinson's-related freezing episodes or falls in the past 6 months
• People with any condition that could make a lumbar puncture (spinal tap) complicated or unsafe, in the opinion of the study doctor
• People with a significant history of allergic reaction to local anaesthetic or related medicines used during spinal fluid collection
• People who have reported serious thoughts of suicide (as assessed by a standard rating scale)
• People currently taking certain medicines known as MATE2k substrates (confirm with trial site)
• People who plan to receive, or have recently received, certain specific Parkinson's-related or other medicines listed in the protocol within 7 days or 5 half-lives before the first dose and during the study
• People with significantly abnormal blood, urine, or clotting test results within 45 days before the first dose
• People who cannot communicate effectively with the study team
• People who have taken part in a study of a new medicine within the previous 3 months or five half-lives
• People who have donated 450 mL or more of blood in the 3 months before the first study dose
• Women who are pregnant, breastfeeding, or currently lactating
• People with a significantly abnormal heart tracing (ECG)
• People with a recent COVID-19 infection whose symptoms have not fully resolved
• People who have received a COVID-19 vaccine between the screening visit and the first dose
• People with a significant history of drug or alcohol misuse within the past 2 years, or who are currently prescribed treatment for Parkinson's disease symptoms
• People with any history of allergies or atopy, including severe skin reactions or delayed-type hypersensitivity reactions
• People with a current or past history of abnormally high eosinophil levels (a type of white blood cell) where the cause is unknown or ongoing
• People with a history of Erythema Multiforme (a severe skin condition) or identified risk factors for it
• People for whom a PET or MRI scan would not be safe, as determined during screening
• People with a significant history of allergic reaction to a specific PET scan substance called [18F] FDG
• People who have previously been exposed to ionising radiation in research studies (confirm acceptable limits with trial site)
• People with chronic kidney disease, as defined by specific test results at screening
• People with significant liver disease or abnormal liver function test results, or severe liver cirrhosis
• People with uncontrolled type 1 or type 2 diabetes
• People with current symptomatic hay fever, or a history of hay fever that affects more than the nose and eyes

Important: Always verify eligibility with the trial site directly before applying.