An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: 0.04 mg Lu AE04621; 0.08 mg Lu AE04621; 0.2 mg Lu AE04621; 0.4 mg Lu AE04621; 0.6 mg Lu AE04621; 0.8 mg Lu AE04621; 1.0 mg Lu AE04621; 1.2 mg Lu AE04621
Intervention description: 0.04 mg dose group; 0.08mg dose group; 0.2 mg dose group; 0.4 mg dose group; 0.6 mg dose group; 0.8 mg dose group; 1.0 mg dose group; 1.2 mg dose group
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients (men and/or women). The dosing regimen planned for Cohort 1 was a dose of 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, and a dose of 0.6 mg Lu AE04621 on Day 3. • The dosing regimen planned for Cohort 2 was 0.4 mg Lu AE04621 on Day 1 followed by a dose of 0.6 mg Lu AE04621 on Day 2, and a dose of 0.8 mg Lu AE04621 on Day 3. The dosing regimen planned for Cohort 3 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.0 mg Lu AE04621 on Day 4. The dosing regimen planned for Cohorts 4 and 5 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.2 mg Lu AE04621 on Day 4. The results are presented by dose groups and are based on the actual doses administered.
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and
      metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is diagnosed with idiopathic Parkinson Disease (consistent with the UK
             Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD).

          -  The patient's Hoehn and Yahr Staging score is ≤ 3 in the "ON" state.

          -  The patient experiences motor fluctuations with at least 2.5 hours of "OFF" periods in
             the awake time and has predictable morning "OFF" episodes, which have been consistent
             within the past 4 weeks.

          -  The patient currently has a good response to L-DOPA and has been receiving a stable
             dose of L-DOPA (≥3 doses per day of standard L-DOPA or ≥3 doses per day of Carbidopa
             and L-DOPA, Extended-Release Capsules) during at least four weeks prior to screening.

        Exclusion Criteria:

          -  The patient has cognitive impairment, defined as a Mini Mental State Examination(MMSE)
             score ≤ 26 at the Screening Visit.

          -  The patient has severe disabling dyskinesia

          -  The patient takes or has taken disallowed recent or concomitant medication (CYP2D6
             inhibitors, CYP 3A4 substrate, Dopamine agonists, 5 HT3 antagonists, Anti-viral
             (Amantadine))

        Other protocol defined inclusion and exclusion criteria may apply