Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects

UCB

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Rotigotine, Period 1

Drug: Rotigotine, Period 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT01675024

SP0913

Details and patient eligibility

About

This study is to characterize the Pharmacokinetics (PK) of unconjugated and total Rotigotine after single and multiple doses of Rotigotine transdermal patch, and also to investigate the safety and tolerability of Rotigotine transdermal patch in healthy Chinese subjects.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Chinese subjects
Healthy volunteers with normal body weight, female subject is willing to use a double contraceptive barrier method or an oral hormonal contraceptive during the entire study

Exclusion criteria

Previously participated in any Rotigotine study or participated in another clinical study for an investigational drug
History of drug or alcohol abuse within the last 2 years
Suicide attempt or suicidal ideation in the past 6 months
Transient ischemic attack or stroke within the last 12 months
Current condition of epilepsy and / or seizures
History of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
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 wellbeing or ability to participate in this study
Subject has a QTcB (QT interval corrected for heart rate according to Bazett's formula) interval of ≥ 450 ms for female or ≥ 430 ms for male
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 tested positive for human immunodeficiency virus antibodies (HIV)-1 / 2Ab, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV-Ab)
Subject has a positive urine drug screen and / or alcohol breath test on Day 1
Subject has made a blood donation or had a comparable blood loss (> 400 mL)
Subject smokes or has done so within 6 months prior to Eligibility Assessment (EA)
Subject has a clinically relevant allergy
Subject is currently taking any medication
Female subject is currently taking an oral hormonal contraceptive
Subject has symptomatic orthostatic hypotension
Subject has a pulse rate at rest less than 45 beats per minute (bpm) or more than 100 bpm
Subject has a systolic blood pressure (SBP) lower than 100 mmHg or higher than 140 mmHg or diastolic blood pressure (DBP) higher than 90 mmHg
Subject has a current or a history of clinically relevant motor disturbance, impairment of memory, sleep disturbance or neurodegenerative disease
Subject has consumed more than 3 cups (more than 450 ml) of caffeinated beverages per day
Subject's abdomen is thickly covered with hair resulting in difficulties in finding appropriate patch application sites