Healthy
Conditions
Keywords
Rotigotine, Neupro, Japanese, Caucasian, Male, Female, Single dose, Pharmacokinetics
Brief summary
To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian female and male healthy subjects.
Interventions
DRUGRotigotine transdermal patch 1mg / 24 hours
Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours
DRUGRotigotine transdermal patch 2 mg / 24 hours
Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours
DRUGRotigotine transdermal patch 4 mg / 24 hours
Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours
Sponsors
UCB BIOSCIENCES GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, ECG, hematology, clinical chemistry, urinalysis) * Subject is of normal body-weight as determined by a body mass index ranging between 18 to 28 kg/m² * Subject is Japanese or Caucasian. Japanese subjects are born in Japan and left Japan not more than 10 years ago. Both parents of the Japanese subjects are 100 % Japanese
Exclusion criteria
* Subjects (females) without medically adequate contraception or on lactation or pregnant women. Subjects with oral contraception or hormone replacement within 4 weeks prior to eligibility assessment * Subject has a history of chronic alcohol or drug abuse * Subject has a consumption of more than 20 g of alcohol/day (amount corresponds to 0.5 l of beer/day or 0.25 l of wine/day or 3 glasses (à 2 cl) of liquor/day) * Subject has a clinically relevant allergy * Subject has a known or suspected drug hypersensitivity in particular, to any component of the trial medication * Subject has any clinically significant abnormality in physical examination * Subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100 bpm * Subject has systolic blood pressure lower than 100 mmHg or higher than 145 mmHg or diastolic blood pressure higher than 95 mmHg or lower than 60 mmHg * Subject has an atopic or eczematous dermatitis and/or an active skin disease or skin tumors * Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval (AUCtau,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state (Cmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of total Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)] | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Maximum concentration of unconjugated Rotigotine in plasma at steady-state (Cmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life (t1/2) of unconjugated Rotigotine in steady-state | Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours |
| Time of maximum concentration (tmax) of unconjugated Rotigotine in steady-state (tmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent volume of distribution of unconjugated Rotigotine normalized by Body Weight (Vz/f/BW) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours |
| Terminal half-life (t1/2) of total Rotigotine in steady-state | Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours |
| Time of maximum concentration (tmax) of total Rotigotine in steady-state (tmax,ss) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent total body clearance of total Rotigotine normalized by Body Weight (CL/f/BW) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
| Apparent volume of distribution of total Rotigotine normalized by Body Weight (Vz/f/BW) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours |
| Apparent total body clearance of unconjugated Rotigotine normalized by Body Weight (CL/f/BW) | Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours |
Countries
Germany
Outcome results
None listed