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

December 3, 2012 updated by: UCB Pharma

A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rotigotine, Period 1
In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.
Drug: 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

Other Names:
  • Neupro
Experimental: 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.
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

Other Names:
  • Neupro

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12
Period 2; Day 7 to Day 14 of study
Plasma concentrations of total Rotigotine for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Plasma concentrations of total Rotigotine for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12
Period 2; Day 7 to Day 14 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration (AUC 0-tz) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Maximum plasma concentration (Cmax) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero to 24 hours at steady state (AUC(0-24h),ss) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure
Maximum plasma concentration at steady state (Cmax,ss) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Terminal half-life (t½) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1)
Time Frame: Period 1; Day1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day1 to Day 3 of study
Lag time until first concentration ≥ limit of quantitation (LOQ) (tlag) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Maximum plasma concentration normalized by Body Weight (kg) (Cmax, norm (BW)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Maximum plasma concentration normalized by apparent dose (mg)(Cmax, norm (apparent dose)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Maximum plasma concentration normalized by drug content of patch (mg) (Cmax, norm (mgdc)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg) (AUC(0-tz), norm (BW)) for single-dose application (Period 1)
Time Frame: Perion 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Perion 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg) (AUC(0-tz), norm (apparent dose)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by drug content of patch (mg) (AUC(0-tz), norm (mgdc)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity (AUC(0-∞)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg) (AUC(0-∞), norm (apparent dose)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg) (AUC(0-∞), norm (BW)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Area under the plasma concentration-time curve from zero up to infinity normalized by drug content of patch (mg) (AUC(0-∞), norm (mgdc)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Apparent total body clearance (CL/F) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Apparent volume of distribution (Vz/f) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Mean residence time (MRT) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Rate constant of elimination (ke) for single-dose application (Period 1)
Time Frame: Period 1; Day 1 to Day 3 of study
Period 1; Pharmacokinetic (PK) samples will be taken predose and 1, 2, 3, 4, 8, 12, 16, 24, 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 1
Period 1; Day 1 to Day 3 of study
Terminal half-life (t½) for multiple-dose application
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours after patch application on Day 12
Period 2; Day 7 to Day 14 of study
Time to reach a maximum plasma concentration at steady state (tmax,ss) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Maximum plasma concentration at steady state normalized by body weight (kg) (Cmax,ss,norm(BW)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Maximum plasma concentration at steady state normalized by apparent dose (mg) (Cmax, ss, norm (apparent dose)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure.
Maximum plasma concentration at steady state normalized by drug content of patch (mg) (Cmax, ss, norm (mgdc)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure
Minimum plasma concentration at steady state (Cmin, ss) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure
Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by body weight (kg) (AUC(0-24h), ss, norm (BW)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure
Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by apparent dose (mg) (AUC(0-24), ss, norm (apparent dose)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure
Area under the plasma concentration-time curve from zero to 24 hours at steady state normalized by drug content of patch (mg) (AUC(0-24), ss, norm (mgdc)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12
Period 2; Day 9 to Day 12 of study for this Outcome Measure
Apparent total body clearance (CL/F) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
Period 2; Day 7 to Day 14 of study
Apparent total body clearance normalized by body weight (kg) (CL/F norm (BW)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
Period 2; Day 7 to Day 14 of study
Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
Period 2; Day 7 to Day 14 of study
Apparent volume of distribution normalized by body weight (kg) (Vz/f norm (BW)) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
Period 2; Day 7 to Day 14 of study
Mean residence time (MRT) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
Period 2; Day 7 to Day 14 of study
Rate constant of elimination (ke) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 7 to Day 14 of study
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 7, 8, 9, 11 and 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12 and 25, 26, 28, 30, 32, 36, 40, 48, 60 and 72 hours on Day 12.
Period 2; Day 7 to Day 14 of study
Peak to trough fluctuation (PTF) for multiple-dose application (Period 2)
Time Frame: Period 2; Day 9 to Day 12 of study for this Outcome Measure
Period 2; Pharmacokinetic (PK) samples will be taken prior to patch application on Day 9 and Day 12 and 1, 2, 3, 4, 8, 12, 16 and 24 hours after patch application on Day 9 and Day 12.
Period 2; Day 9 to Day 12 of study for this Outcome Measure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SP0913

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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