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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-state

Time 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

Page last updated: August 23, 2015

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