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:

For Parts A and B (Healthy Volunteer sections):

• People who are Japanese men aged 18 to 44 years old at the time of giving consent to join the study.
• People whose body mass index (a measure of body weight relative to height) is between 18.5 and 25.0 at the screening appointment.
• People who have been fully informed about the study, understood its purpose, and have freely chosen to sign a consent form to participate.

For Part C (Parkinson's disease section):

• People who have been diagnosed with idiopathic Parkinson's disease (Parkinson's disease with no known cause) according to a specific set of international diagnostic guidelines from 2015.
• People whose Parkinson's disease has been rated at Stage 3 or below on the modified Hoehn and Yahr scale, which measures how advanced the condition is.
• People who are either not currently taking any Parkinson's medication, or who have been on a stable dose of one of the following medications for at least 8 weeks before screening with no planned changes during the study: selegiline (up to 5 mg twice daily), rasagiline (up to 1 mg once daily), or immediate-release carbidopa/levodopa (up to 25/100 mg three times daily).
• People whose stool consistency, measured using the Bristol Stool Scale, averages a score of 3 or below, or who have fewer than two bowel movements per week (confirm with trial site for how this is assessed over time).
• People aged 40 to 84 years old at the time of giving consent to join the study.
• People whose body mass index is between 18.5 and 32.0 at the screening appointment.
• Women who have been through menopause for at least one year at the time of giving consent, including menopause that occurred as a result of having the uterus or ovaries surgically removed.
• People who have been fully informed about the study, understood its purpose, and have freely chosen to sign a consent form to participate.

Who may not be able to join:

For Parts A and B:

• People who have significant medical conditions affecting the heart, nervous system, lungs, liver, kidneys, metabolism, digestive system, urinary tract, immune system, hormones, or mental health, or any other condition that could affect safety or the study results.
• People who have a current or past condition, or have had surgery, affecting the digestive tract, liver, kidneys, or other organs in a way that could change how the body processes medication.
• People who have taken any medication — including non-prescription medicines — in the 7 days before the first dose of the study drug.
• People who have a seizure disorder such as epilepsy, or a history of one.
• People who have allergies or a history of allergies to medications or foods.
• People with a tendency toward allergic reactions who the lead researcher considers unsuitable for the study.
• People who currently have or have previously had dependence on alcohol or drugs.
• People who have donated 400 mL or more of whole blood in the past 12 weeks, 200 mL or more of whole blood in the past 4 weeks, or any blood components in the past 2 weeks before the first study dose.
• People who tested positive at screening for hepatitis B surface antigen, hepatitis C antibody, HIV antigen or antibody, or syphilis.
• People who are not willing to use appropriate contraception from the time of consent through to the final study visit.
• People who, at screening, indicated certain thoughts of suicide on a specific standardised questionnaire (the Columbia-Suicide Severity Rating Scale, questions 4 or 5), or who have had any history of suicidal behaviour in the 6 months before screening.
• People who took part in another clinical trial and received an experimental treatment within 4 months before the first dose of the study drug.
• People considered unsuitable by the lead researcher based on any screening or assessment findings.

For Part C:

• People whose parkinsonism is caused by medication, a metabolic or genetic brain disorder, brain inflammation, or conditions classed as Parkinson-plus syndromes or other atypical forms of parkinsonism.
• People who experience freezing of gait (sudden temporary inability to move the feet when walking).
• People who have previously had brain surgery for Parkinson's disease, such as pallidotomy, deep brain stimulation, or fetal tissue transplantation.
• People who have significant medical conditions affecting the heart, nervous system, lungs, liver, kidneys, metabolism, digestive system, urinary tract, immune system, hormones, or mental health (other than Parkinson's disease itself), or any other condition that could affect safety or the study results.
• People who have a current or past condition, or have had surgery, affecting the digestive tract, liver, kidneys, or other organs in a way that could change how the body processes medication.
• People who have a seizure disorder such as epilepsy, or a history of one.
• People who are currently taking blood-thinning medications (antiplatelet agents or anticoagulants).
• People who have allergies or a history of allergies to medications or foods.
• People with a tendency toward allergic reactions who the lead researcher considers unsuitable for the study.
• People who currently have or have previously had dependence on alcohol or drugs.
• People who have donated 400 mL or more of whole blood in the past 16 weeks, 200 mL or more of whole blood in the past 4 weeks, or any blood components in the past 2 weeks before the first study dose.
• People who tested positive at screening for hepatitis B surface antigen, hepatitis C antibody, HIV antigen or antibody, or syphilis.
• People who are not willing to use appropriate contraception from the time of consent through to the final study visit.
• People who, at screening, indicated certain thoughts of suicide on a specific standardised questionnaire (the Columbia-Suicide Severity Rating Scale, questions 4 or 5), or who have had any history of suicidal behaviour in the 6 months before screening.
• People who took part in another clinical trial and received an experimental treatment within 4 months before the first dose of the study drug.
• People considered unsuitable by the lead researcher based on any screening or assessment findings.

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