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

UCB

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease

Treatments

Other: Placebo

Drug: Rotigotine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01964573

SP0885

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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