A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria: Part 1 ND0612-005a:
- Healthy males or non-pregnant, non-lactating healthy females
- Age 40 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study (Part 1 only for subjects assigned to ND0612L and Part 1 and Part 2 for subjects assigned to ND0612H)
- Must provide written informed consent
- Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration)
- Must agree to use an adequate method of contraception
Inclusion Criteria: Part 2 ND0612-005b:
1. Subjects who were dosed with ND0612H (any replacements subjects enrolled in Part 2 will be dosed with the optimal LD/CD concentration of ND0612H after completion of Part 2).
Exclusion Criteria:
- Participation in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
- Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
- Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1)
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol, hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days before IMP administration (See Section 11.4). Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study as agreed by the PI and sponsor's medical monitor
- Use of any non-selective monoamine oxidase (MAO) inhibitors within 2 weeks of screening
- History or presence of glaucoma
- History or presence of suspicious undiagnosed skin lesions or a history of melanoma
- Any history of psychoses or seizure
- Known hypersensitivity to Sinemet® or domperidone or any of the excipients
- Any history or presence of Prolactin-releasing pituitary tumour (prolactinoma)
- Any medical history of GI haemorrhage, mechanical obstruction or perforation
- Any history of moderate or severe hepatic impairment
- Subjects with clinically significant liver function tests
- Subjects with QTc >450 ms at screening
- Subjects with significant electrolyte disturbances
- Subjects with any underlying cardiac disease
- Subjects who have received QT-prolonging drugs or potent cytochrome P450 (CYP) 3A4 inhibitors within 4 weeks of screening
- ND0612H arm only: Subjects who have sinus problems
- ND0612H arm only: Subjects who have regular heartburn and/or indigestion
- ND0612H arm only: Subjects who have had abdominal (bowel) surgery
- ND0612H arm only: Any clinically significant findings observed during naso-jejunal tube placement as determined by the endoscopist
- Failure to satisfy the investigator of fitness to participate for any other reason
Sites / Locations
- Quotient Clinical LTD
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
ND0612L (LD/CD solution)
ND0612H (LD/CD solution)
LCIG (Levodopa-carbidopa intestinal gel)
3 doses of the investigational ND0612L (LD/CD solution) for subcutaneous (SC) infusion 0.24ml per hour.
3 doses of the investigational ND0612H (LD/CD solution) for subcutaneous (SC) infusion 0.64ml per hour.
Active Comparator: LCIG subjects who completed the ND0612H arm will be administered with 3 doses of LCIG, directly to the jejunum.