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

NCT ID: NCT01675024

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-09-30

Brief Summary

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.

Conditions

Healthy

Keywords

Neupro, Pharmacokinetics, healthy Chinese subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotigotine, Period 1

In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.

Group Type: EXPERIMENTAL

Rotigotine, Period 1

Intervention Type: DRUG

Formulation: transdermal

Dosage: 2 mg / 24 hours once at Day 2

Frequency: once every 24 hours

Duration: from Day 1 to Day 3

Rotigotine, Period 2

In Period 2 (Day 7 to Day 14) all 24 subjects will receive 2 mg / 24 hours for 3 days then 4 mg / 24 hours for 3 days.

Group Type: EXPERIMENTAL

Rotigotine, Period 2

Intervention Type: DRUG

Formulation: transdermal

Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12

Frequency: once every 24 hours

Duration: from Day 1 to Day 3

Interventions

Rotigotine, Period 1

Formulation: transdermal

Dosage: 2 mg / 24 hours once at Day 2

Frequency: once every 24 hours

Duration: from Day 1 to Day 3

Intervention Type: DRUG

Rotigotine, Period 2

Formulation: transdermal

Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12

Frequency: once every 24 hours

Duration: from Day 1 to Day 3

Intervention Type: DRUG

Other Intervention Names

Neupro; Neupro

Eligibility Criteria

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

• Minimum Eligible Age: 18 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

Locations

Shanghai, , China

Countries

China

References

Liu Y, Tomlinson B, Guo J, Asgharnejad M, Bauer L, Surmann E, Guo X, Elshoff JP. Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects. Clin Ther. 2018 Jul;40(7):1108-1121.e8. doi: 10.1016/j.clinthera.2018.05.009.

Reference Type: DERIVED

PMID: 30098648 (View on PubMed)

Other Identifiers

SP0913

Identifier Type: -

Identifier Source: org_study_id