Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects

Trial end date:
Target enrollment:
Participant gender:
The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose applications of the Rotigotine transdermal patch in healthy young male and female Korean subjects to be submitted to MFDS for new drug application approval.
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Lead Sponsor:
UCB Pharma
N 0437
Inclusion Criteria:

- Subject is male or female and aged between 19 and 45 years of age (inclusive)

- Subject is healthy (no clinically relevant findings in any of the investigations of
the pre-examination) as judged by the investigator

- Subject is of normal body weight as determined by a Body Mass Index (BMI) between 18
and 28 kg / m²

- Subject is Korean (both parents are pure Korean)

Exclusion Criteria:

- Subject has had a history of drug or alcohol abuse within the last 2 years

- Subject has had a history of transient ischemic attack or stroke within the last 12

- Subject has a history or current condition of Epilepsy and / or seizures

- Subject has a history of significant skin hypersensitivity to adhesives or other
transdermal products or recently unsolved Contact Dermatitis

- Subject has a history or present condition of an Atopic or Eczematous Dermatitis,
Psoriasis, and / or an active skin disease

- Female subject is pregnant or lactating

- Subject has any medical or psychiatric condition that, in the opinion of the
investigator, could jeopardize or would compromise the subject's ability to
participate in this trial

- Subject has a QTcB (according to Bazett´s formula) interval of ≥ 450 ms for female or
≥ 430 ms for male or any other clinically relevant Electrocardiogram (ECG) finding

- Subject has any clinically relevant abnormality in the physical examination, or any
clinically relevant deviation from the normal range in the clinical chemistry,
hematology, or urinalysis

- Subject has a relevant hepatic dysfunction (total Bilirubin > 2 mg /dL or Alanine
Aminotransferase [ALT] or Aspartate Aminotransferase [AST] greater than 2 times the
upper limit of the normal reference range)

- Subject has a positive test for Human Immunodeficiency Virus antibodies (HIV)-1/2Ab,
Hepatitis B surface Antigen (HBsAg) or Hepatitis C Virus Antibody (HCV-Ab)

- Subject has a positive test for alcohol or drugs

- Subject consumes more than 150 g of alcohol / week

- Subject has made a blood donation or had a comparable blood loss (> 400 ml) within the
last 3 months

- Subject smokes more than 5 cigarettes per day or has done so within previous 6 months

- Subject has a clinically relevant allergy

- Subject is taking any medication (excluding oral hormonal contraceptive) currently or
within 2 weeks prior to the first day of dosing (with the exception of Acetaminophen
[up to 1000 mg per day per os] which may have been taken up to 48 hours prior to
commencement of dosing)

- Female subject is currently taking an oral hormonal contraceptive but less than 2

- Subject has a symptomatic orthostatic hypotension with a decrease of Blood Pressure
(BP) from supine to standing position of ≥ 20 mmHg in systolic BP or of ≥ 10 mmHg in
diastolic BP after 1 and / or 3 minutes

- Subject has a pulse rate at rest less than 45 beats per minute or more than 100 beats
per minute (measured in supine position)

- Subject has a systolic Blood Pressure (BP) lower than 100 mmHg or higher than 150 mmHg
or diastolic BP higher than 95 mmHg (measured in supine position)

- Subject has a current or a history of clinically relevant motor disturbance,
impairment of memory, sleep disturbance or neurodegenerative disease (e.g. , Alzheimer
Dementia, Diffuse, Lewy Body Dementia, Amyotrophic Lateral Sclerosis [ALS], Multiple

- Subject has taken herbal medicine therapy within the last 2 weeks

- Subject consumes more than 3 cups (more than 450 ml) of caffeinated beverages per day
within the last 2 weeks