Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Rotigotine transdermal patch 1mg / 24 hours (Drug); Rotigotine transdermal patch 2 mg / 24 hours (Drug); Rotigotine transdermal patch 4 mg / 24 hours (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: UCB BIOSCIENCES GmbH Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
Summary
To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine
in Japanese and Caucasian female and male healthy subjects.
Clinical Details
Official title: Parallel Group Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Repeated Dose Treatment With Rotigotine Continuous Delivery System (5 cm^2/2.25 mg, 10 cm^2/4.5 mg, 20 cm^2/9 mg) in Japanese and Caucasian Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss)Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)] Maximum concentration of unconjugated Rotigotine in plasma at steady-state (Cmax,ss) Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)] Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)] Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)] Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval (AUCtau,ss) Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)] Maximum concentration of total Rotigotine in plasma at steady-state (Cmax,ss) Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)] Maximum concentration of total Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)] Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]
Secondary outcome: Terminal half-life (t1/2) of unconjugated Rotigotine in steady-stateTime of maximum concentration (tmax) of unconjugated Rotigotine in steady-state (tmax,ss) Apparent total body clearance of unconjugated Rotigotine normalized by Body Weight (CL/f/BW) Apparent volume of distribution of unconjugated Rotigotine normalized by Body Weight (Vz/f/BW) Terminal half-life (t1/2) of total Rotigotine in steady-state Time of maximum concentration (tmax) of total Rotigotine in steady-state (tmax,ss) Apparent total body clearance of total Rotigotine normalized by Body Weight (CL/f/BW) Apparent volume of distribution of total Rotigotine normalized by Body Weight (Vz/f/BW)
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is healthy according to assessments done at eligibility assessment (medical
history, physical examination, blood pressure, heart rate, ECG, hematology, clinical
chemistry, urinalysis)
- Subject is of normal body-weight as determined by a body mass index ranging between
18 to 28 kg/m²
- Subject is Japanese or Caucasian. Japanese subjects are born in Japan and left Japan
not more than 10 years ago. Both parents of the Japanese subjects are 100 % Japanese
Exclusion Criteria:
- Subjects (females) without medically adequate contraception or on lactation or
pregnant women. Subjects with oral contraception or hormone replacement within 4
weeks prior to eligibility assessment
- Subject has a history of chronic alcohol or drug abuse
- Subject has a consumption of more than 20 g of alcohol/day (amount corresponds to 0. 5
l of beer/day or 0. 25 l of wine/day or 3 glasses (à 2 cl) of liquor/day)
- Subject has a clinically relevant allergy
- Subject has a known or suspected drug hypersensitivity in particular, to any
component of the trial medication
- Subject has any clinically significant abnormality in physical examination
- Subject has a heart rate at rest less than 50 beats per minute (bpm) or more than 100
bpm
- Subject has systolic blood pressure lower than 100 mmHg or higher than 145 mmHg or
diastolic blood pressure higher than 95 mmHg or lower than 60 mmHg
- Subject has an atopic or eczematous dermatitis and/or an active skin disease or skin
tumors
- Subject has a history of significant skin hypersensitivity to adhesives or other
transdermal products or recent unresolved contact dermatitis
Locations and Contacts
1, Neuss, Germany
Additional Information
Starting date: December 2002
Last updated: October 17, 2014
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