Trial record 19 of 35 for:    Arnold-Chiari Malformation

Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects

This study has been completed.
Sponsor:
Collaborators:
Schwarz BioSciences GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01761526
First received: January 3, 2013
Last updated: October 17, 2014
Last verified: January 2013
  Purpose

To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian Female and Male Healthy Subjects.


Condition Intervention Phase
Healthy
Drug: Rotigotine transdermal patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Parallel Group Trial to Evaluate the Pharmacokinetics and Safety / Tolerability of Single-Dose Treatment With Rotigotine Continuous Delivery System (10 cm2 / 4.5 mg) in Japanese and Caucasian Healthy Subjects

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Area under the concentration-time curve (AUC) from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized [AUC (0-t)norm] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax,norm] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) [AUC (0-t)] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero up to the last measured concentration greater than the Lower Limit of Quantitation (LOQ) normalized by body weight [AUC (0-t)] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma [Cmax] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Maximum concentration in plasma normalized by body weight [Cmax, norm] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose


Secondary Outcome Measures:
  • Terminal half-life [t1/2] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Time of maximum concentration [tmax] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Total body clearance (CL) of unconjugated Rotigotine normalized by body weight (BW) [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Apparent volume of distribution of unconjugated Rotigotine normalized by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Amounts of unconjugated Rotigotine excreted in urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Fraction of unconjugated Rotigotine excreted into urine [fe (% of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Renal Clearance [CLR] of unconjugated Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Terminal half-life [t1/2] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Time of maximum concentration [tmax] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Total body clearance of total Rotigotine normalized by body weight [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Apparent volume of distribution normalized of total Rotigotine by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Amount of total Rotigotine excreted into urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Fraction of total Rotigotine excreted into urine [fe (% of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Renal clearance [CLR] of total Rotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Terminal half-life [t1/2] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Time of maximum concentration [tmax] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Total body clearance of total Despropylrotigotine normalized by body weight [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Apparent volume of distribution of total Despropylrotigotine normalized by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Amount of total Despropylrotigotine excreted into urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Fraction of total Despropylrotigotine excreted into urine [fe (% of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Renal Clearance [CLR] of total Despropylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Terminal half-life [t1/2] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Time of maximum concentration [tmax] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Area under the concentration-time curve from zero to infinity [AUC (0-inf)] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Total body clearance of total Desthienylethylrotigotine normalized by body weight [CL/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Apparent volume of distribution of total Desthienylethylrotigotine normalized by body weight [Vz/f/BW] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Amount of total Desthienylethylrotigotine excreted into urine [Ae] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Fraction of total Desthienylethylrotigotine excreted into urine [fe (%of dose)] [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose

  • Renal clearance [CLR] of total Desthienylethylrotigotine [ Time Frame: From Baseline (0 hours Pre-Dose) up to 60 hours Post-Dose ] [ Designated as safety issue: No ]
    Blood sampling at 0 hours (Pre-Dose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours, and 60 hours Post-Dose


Enrollment: 50
Study Start Date: October 2002
Study Completion Date: December 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine in Healthy Japanese
  • Rotigotine transdermal patch
  • Single dose application of 2 mg / 24 hours Rotigotine in Healthy Japanese subjects
  • Transdermal patch over 24 hours
Drug: Rotigotine transdermal patch
Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
Other Name: Neupro
Experimental: Rotigotine in Caucasian
  • Rotigotine transdermal patch
  • Single-Dose application of 2 mg / 24 hours Rotigotine in healthy Caucasian subjects
  • Transdermal patch over 24 hours
Drug: Rotigotine transdermal patch
Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
Other Name: Neupro

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is healthy according to assessments done at eligibility assessment (medical history, physical examination, blood pressure, heart rate, Electrocardiogram (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 (e.g. mechanical contraception (Intrauterine-Device IUD), sterilization, hysterectomy) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761526

Locations
Germany
01
Neuss, Germany
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Schwarz BioSciences GmbH
Alfred-Nobel-Str. 10
40789 Monheim am Rhein
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01761526     History of Changes
Other Study ID Numbers: SP0717
Study First Received: January 3, 2013
Last Updated: October 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB Pharma:
Rotigotine
Neupro
Japanese
Caucasian
Male
Female
Single dose
Pharmacokinetics

Additional relevant MeSH terms:
N 0437
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014