Conditions: Parkinson Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief 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.

Detailed description:
The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days, with increasing dose each day.

Dosing regimen will be decided at a dosing conferences. Dose levels can be increased, maintained or reduced both between cohorts but also within same cohort. The results are presented by dose level and reflect the actual doses administered.

A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.

Arms:
arm 1: Patients having received a dose of 0.04 mg, independent of which Cohort they belong to. arm 2: Patients having received a dose of 0.08 mg, independent of which Cohort they belong to. arm 3: Patients having received a dose of 0.2 mg, independent of which Cohort they belong to. arm 4: Patients having received a dose of 1.2 mg, independent of which Cohort they belong to. arm 5: Patients having received a dose of 0.6 mg, independent of which Cohort they belong to. arm 6: Patients having received a dose of 0.8 mg, independent of which Cohort they belong to. arm 7: Patients having received a dose of 1.0 mg, independent of which Cohort they belong to. arm 8: Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.

Interventions: intervention 1: 0.04 mg Lu AE04621 intervention 2: 0.08 mg Lu AE04621 intervention 3: 0.2 mg Lu AE04621 intervention 4: 0.4 mg Lu AE04621 intervention 5: 0.6 mg Lu AE04621 intervention 6: 0.8 mg Lu AE04621 intervention 7: 1.0 mg Lu AE04621 intervention 8: 1.2 mg Lu AE04621
Intervention descriptions: intervention 1: 0.04 mg dose group intervention 2: 0.08mg dose group intervention 3: 0.2 mg dose group intervention 4: 0.4 mg dose group intervention 5: 0.6 mg dose group intervention 6: 0.8 mg dose group intervention 7: 1.0 mg dose group intervention 8: 1.2 mg dose group

Protocol document: