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Completed

NCT Number: NCT01854216

Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects

To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese and Caucasian female and male healthy subjects.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1

Neuss, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotigotine transdermal patch 1mg / 24 hours

Drug

Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours

Other names: Neupro

Rotigotine transdermal patch 2 mg / 24 hours

Drug

Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours

Other names: Neupro

Rotigotine transdermal patch 4 mg / 24 hours

Drug

Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours

Other names: Neupro

Primary outcomes

  1. Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval (AUCtau,ss)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  2. Area under the concentration-time curve of unconjugated Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  3. Maximum concentration of unconjugated Rotigotine in plasma at steady-state (Cmax,ss)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  4. Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  5. Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  6. Maximum concentration of unconjugated Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  7. Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval (AUCtau,ss)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  8. Area under the concentration-time curve of total Rotigotine in steady-state within one dosing interval normalized by Body Weight [AUCtau,ss,norm(BW)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  9. Maximum concentration of total Rotigotine in plasma at steady-state (Cmax,ss)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  10. Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight [Cmax,ss,norm(BW)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  11. Maximum concentration of total Rotigotine in plasma at steady-state normalized by apparent dose [Cmax,ss,norm(appd)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  12. Maximum concentration of total Rotigotine in plasma at steady-state normalized by Body Weight and apparent dose [Cmax,ss,norm(BW,appd)]

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

Secondary outcomes

  1. Terminal half-life (t1/2) of unconjugated Rotigotine in steady-state

    Time frame: Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours

  2. Time of maximum concentration (tmax) of unconjugated Rotigotine in steady-state (tmax,ss)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  3. Apparent total body clearance of unconjugated Rotigotine normalized by Body Weight (CL/f/BW)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  4. Apparent volume of distribution of unconjugated Rotigotine normalized by Body Weight (Vz/f/BW)

    Time frame: Blood sampling at 0 hours (predose), 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

  5. Terminal half-life (t1/2) of total Rotigotine in steady-state

    Time frame: Blood sampling at 24 hours, 25 hours, 26 hours, 28 hours, 30 hours, 33 hours, 36 hours, 48 hours

  6. Time of maximum concentration (tmax) of total Rotigotine in steady-state (tmax,ss)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  7. Apparent total body clearance of total Rotigotine normalized by Body Weight (CL/f/BW)

    Time frame: Blood sampling at 0 hours (predose), 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, and 24 hours

  8. Apparent volume of distribution of total Rotigotine normalized by Body Weight (Vz/f/BW)

    Time frame: Blood sampling at 0 hours (predose), 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

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
May 15, 2013
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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