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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma
• Treatments: N 0437; Rotigotine

Criteria

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 months

• 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 months

• 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 Sclerosis)

• 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