This study is an open-label of single transdermal dose of DSP-9632P to evaluate the dopamine release derived from levodopa in brain, and a randomized, double-blind, placebo-controlled, 2-way crossover of multiple transdermal doses of DSP-9632P to evaluate the safety and tolerability in patients with levodopa-induced dyskinesia in Parkinson's disease.
This study consists of Part A and Part B. Part A is an open-label part to evaluate the amount of striatal dopamine release derived from levodopa following single transdermal administration of DSP-9632P using 11Craclopride PET in patients with levodopa-induced dyskinesia in Parkinson's disease. Part A consists of screening, Period 1, Period 2, Period 3, Period 4, and follow-up period. Each period consists of 2 days, Day 1 and Day 2. There will be a 7-day or longer washout of DSP-9632P between Periods 3 and 4. Subjects will be hospitalized in each period. Part B is a randomized, double-blind, placebo-controlled, crossover part to evaluate the safety and tolerability of DSP-9632P following multiple transdermal administration in patients with levodopa-induced dyskinesia in Parkinson's disease. Part B consists of screening, placebo lead-in period, baseline period, Period 1, Period 2, and follow-up period. Period 1 and Period 2 consist of 9 days. Subjects will be hospitalized for 10 days 9 nights from baseline period to Period 1 and for 9 days 8 nights in Period 2. There will be a 7-day or longer washout of DSP-9632P between Periods 1 and 2. Subjects will concomitantly use any of the levodopa formulation from the time of informed consent to the end of study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7
Nippon Medical School Hospital
Bunkyo, Tokyo, Japan
Binding potential of 11C-raclopride and Dopamine D2 receptor occupancy by Positron Emission Tomography (PET) in Part A
Evaluate the amount of striatal dopamine release derived from levodopa following single transdermal administration of DSP-9632P using 11C-raclopride PET in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 day
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation in Part B
Evaluate the Incidence of AEs, SAEs, and AEs leading to treatment discontinuation of DSP-9632P following multiple once-daily transdermal administration for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease transdermal administration for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
Change from baseline in Unified Dyskinesia Rating Scale (UDysRS) score in Part A
Evaluate the change from baseline in UDysRS score following single transdermal administration of DSP-9632P in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score in Part A
Evaluate the change from baseline in MDS-UPDRS score following single transdermal administration of DSP-9632P in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation in Part A
Evaluate the Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation of DSP-9632P following single transdermal administration in patients with levodopa-induced dyskinesia in Parkinson's disease
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Multiple dose of DSP-9632P 55.0 mg
Single dose of Levodopa formulation
Time frame: 1 days
Cmax of levodopa in Part A
Evaluate the Cmax of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Time of occurrence of Cmax (tmax) of levodopa in Part A
Evaluate the tmax of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Area under the plasma concentration-time curve (AUC) of levodopa in Part A
Evaluate the AUC of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Terminal elimination half-life (t1/2) of levodopa in Part A
Evaluate the t1/2 of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Summary statistics of plasma concentrations of tandospirone and its metabolite 1-(2-Pyrimidyl) piperazine (1-PP) in Part A
Evaluate the summary statistics of plasma concentrations of tandospirone and 1-PP following single transdermal administration of DSP-9632P in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 1 days
Sum and maximum of change from baseline in UDysRS score in Part B
Evaluate the sum and muximum of change from baseline in UDysRS score following multiple once-daily transdermal administration of DSP-9632P for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
Sum and maximum of change from baseline from MDS-UPDRS score in Part B
Evaluate the sum of change from baseline in MDS-UPDRS score following multiple once-daily transdermal administration of DSP-9632P for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
Cmax of levodopa in Part B
Evaluate the Cmax of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
tmax of levodopa in Part B
Evaluate the tmax of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
AUC of levodopa in Part B
Evaluate the AUC of levodopa following oral administration of levodopa formulation in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
t1/2 of levodopa in Part B
with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days
Summary statistics of Plasma concentrations of tandospirone and 1-PP in Part B
Evaluate the Summary statistics of plasma concentrations of tandospirone and 1-PP following multiple once-daily transdermal administration of DSP-9632P for 7 days in patients with levodopa-induced dyskinesia in Parkinson's disease
Time frame: 7 days