A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: TRIGEL; Duodopa
Intervention description: All patients will receive TRIGEL. Treatment order is determined by randomization.; All patients will receive Duodopa. Treatment order is determined by randomization.
Intervention MeSH terms: Carbidopa, levodopa drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      This study evaluates the continuous addition of entacapone to infused levodopa and carbidopa
      on the pharmacokinetic (PK) profile in patients with advanced Parkinson's disease (PD). All
      patients will receive both study drugs, i.e. TRIGEL (levodopa, carbidopa, and entacapone) and
      Duodopa (levodopa and carbidopa), in randomized order.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide informed consent and judged by the Investigator to have
             decision-making capacity

          2. Advanced levodopa-responsive idiopathic PD currently treated with Duodopa infusion
             since minimum 30 days

          3. 30 years of age or older

          4. BMI between 17.0 and 31.0 kg/m2, both inclusive

          5. Agreed to use adequate contraceptive measures:

        Female patients who have been post-menopausal for more than one year or female patients of
        childbearing potential using a highly efficient method of contraception during the study
        (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants,
        hormone injections, some intrauterine devices, or vasectomised partner]). Oral
        contraceptives in combination with other contraceptives are accepted.

        Male patients being vasectomised or agreeing to use condoms during the study and having a
        partner who is using a highly efficient method of contraception as described above.

        Exclusion Criteria:

          1. Hypersensitivity or allergy to the investigational medicinal product (IMP) or to
             chemically related products

          2. Contraindications for the use of levodopa or carbidopa or entacapone

          3. Needing a daily total dose of Duodopa during study participation exceeding 125 mL

          4. Increased fluctuation in clinical PD symptoms within 7 days prior to Screening

          5. Administration of an investigational drug within 3 months prior to Screening and/or
             current participation in another clinical study involving a pharmaceutical or a
             medical device class III

          6. Use of any forbidden medication as specified in Section 9.6 of the protocol

          7. Known hepatitis B, hepatitis C or HIV infection

          8. Donation of blood or plasma or major blood loss (≥500 mL) within 3 months prior to
             Screening

          9. Positive urine drug test (amphetamine, benzodiazepines, tetrahydrocannabinol, cocaine
             or opiates) at Screening

         10. Known alcohol abuse

         11. Unwilling to meet the requirements of the protocol

         12. Other medical or social reasons for exclusion at the discretion of the Investigator