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

NCT ID: NCT01964573

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-02-28

Brief 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Rotigotine group

Group Type: EXPERIMENTAL

Rotigotine

Intervention Type: DRUG

Day 1-3: 2 mg patch once daily

Day 4-6: 4 mg patch once daily

Placebo group

Placebo matched to rotigotine will be administered in the same way as within the Rotigotine group.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo patches matching with Rotigotine 2 mg patches and 4 mg patches.

Frequency:

Day 1-3: 2 mg patch once daily

Day 4-6: 4 mg patch once daily

Interventions

Rotigotine

Day 1-3: 2 mg patch once daily

Day 4-6: 4 mg patch once daily

Intervention Type: DRUG

Placebo

Placebo patches matching with Rotigotine 2 mg patches and 4 mg patches.

Frequency:

Day 1-3: 2 mg patch once daily

Day 4-6: 4 mg patch once daily

Intervention Type: OTHER

Other Intervention Names

Neupro

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB, Inc.

Role: STUDY_DIRECTOR

+1 877 822 9493

Locations

Seoul, , South Korea

Countries

South Korea

References

Kim BH, Yu KS, Jang IJ, Soo Lim K, Kim JR, Elshoff JP, Andreas JO, Braun M, Cawello W. Pharmacokinetic properties and tolerability of rotigotine transdermal patch after repeated-dose application in healthy korean volunteers. Clin Ther. 2015 Apr 1;37(4):902-12. doi: 10.1016/j.clinthera.2015.01.013. Epub 2015 Mar 16.

Reference Type: DERIVED

PMID: 25791613 (View on PubMed)

Other Identifiers

SP0885

Identifier Type: -

Identifier Source: org_study_id