HealthyPhase 1NCT01675024

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

A Phase 1 study testing Rotigotine, Period 1 and Rotigotine, Period 2 in people with Healthy, run by UCB Pharma at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rotigotine, Period 1 and Rotigotine, Period 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: Aug 2012to Sep 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 24Show fewer

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

Trial locations and contacts

1 site in 1 country.

China1 site

Study site
Shanghai

Other trials in China

About this study

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

Conditions: Healthy
Being tested: Rotigotine, Period 1, Rotigotine, Period 2
Keywords: Neupro, Pharmacokinetics, healthy Chinese subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rotigotine, Period 1Drug
Also called Neupro
Formulation: transdermal
Dosage: 2 mg / 24 hours once at Day 2
Frequency: once every 24 hours
Duration: from Day 1 to Day 3
Rotigotine, Period 2Drug
Also called Neupro
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

Study groups in NCT01675024
Study group	Role	What they receive
Rotigotine, Period 1	Experimental	In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours. Receives: Drug: Rotigotine, Period 1
Rotigotine, Period 2	Experimental	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. Receives: Drug: Rotigotine, Period 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1)
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
Measured: Period 1; Day 1 to Day 3 of study
Plasma concentrations of unconjugated Rotigotine for multiple-dose application (Period 2)
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
Measured: Period 2; Day 7 to Day 14 of study
Plasma concentrations of total Rotigotine for single-dose application (Period 1)
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
Measured: Period 1; Day 1 to Day 3 of study
Plasma concentrations of total Rotigotine for multiple-dose application (Period 2)
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
Measured: 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)
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
Measured: Period 1; Day 1 to Day 3 of study
Maximum plasma concentration (Cmax) for single-dose application (Period 1)
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
Measured: 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)
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
Measured: 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)
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
Measured: Period 2; Day 9 to Day 12 of study for this Primary Outcome Measure

Secondary outcomes (35)

Terminal half-life (t½) for single-dose application (Period 1)
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
Measured: Period 1; Day 1 to Day 3 of study
Time to reach a maximum plasma concentration (tmax) for single-dose application (Period 1)
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
Measured: Period 1; Day1 to Day 3 of study
Lag time until first concentration ≥ limit of quantitation (LOQ) (tlag) for single-dose application (Period 1)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: Period 1; Day 1 to Day 3 of study
Apparent total body clearance (CL/F) for single-dose application (Period 1)
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
Measured: 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)
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
Measured: Period 1; Day 1 to Day 3 of study
Apparent volume of distribution (Vz/f) for single-dose application (Period 1)
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
Measured: 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)
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
Measured: Period 1; Day 1 to Day 3 of study
Mean residence time (MRT) for single-dose application (Period 1)
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
Measured: Period 1; Day 1 to Day 3 of study
Rate constant of elimination (ke) for single-dose application (Period 1)
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
Measured: Period 1; Day 1 to Day 3 of study
Terminal half-life (t½) for multiple-dose application
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: Period 2; Day 7 to Day 14 of study
Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2)
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.
Measured: 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)
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.
Measured: Period 2; Day 7 to Day 14 of study
Mean residence time (MRT) for multiple-dose application (Period 2)
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.
Measured: Period 2; Day 7 to Day 14 of study
Rate constant of elimination (ke) for multiple-dose application (Period 2)
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.
Measured: Period 2; Day 7 to Day 14 of study
Peak to trough fluctuation (PTF) for multiple-dose application (Period 2)
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.
Measured: Period 2; Day 9 to Day 12 of study for this Outcome Measure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Sep 2012

First posted29 Aug 2012 (estimated)
Study startAug 2012
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01675024
Sponsor's protocol ID: SP0913
Status last verified: Dec 2012
First submitted: 27 Aug 2012
Last updated: 4 Dec 2012
Results posted: No
Data monitoring committee: No

Publications

Liu Y, Tomlinson B, Guo J, Asgharnejad M, Bauer L, Surmann E, Guo X, Elshoff JP. Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects. Clin Ther. 2018 Jul;40(7):1108-1121.e8. doi: 10.1016/j.clinthera.2018.05.009.
PubMed 30098648

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine Transdermal Patch in Healthy Chinese Subjects.
ClinicalTrials.gov ID: NCT01675024
Acronym / sponsor ID: SP0913
Conditions: Healthy
Keywords: Neupro, Pharmacokinetics, healthy Chinese subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 29 Aug 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rotigotine, Period 1	Experimental	Drug: Rotigotine, Period 1In Period 1 (Day 1 to Day 3) all 24 subjects will receive only 1 dose 2 mg / 24 hours.
Rotigotine, Period 2	Experimental	Drug: Rotigotine, Period 2In 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.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rotigotine, Period 1Also: NeuproFormulation: transdermal Dosage: 2 mg / 24 hours once at Day 2 Frequency: once every 24 hours Duration: from Day 1 to Day 3	Drug	Rotigotine, Period 1
Rotigotine, Period 2Also: NeuproFormulation: 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	Drug	Rotigotine, Period 2

Primary outcome

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
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
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
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
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
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
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
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

35 secondary outcomes

Terminal half-life (t½) for single-dose application (Period 1)
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
Apparent total body clearance (CL/F) for single-dose application (Period 1)
Time frame: 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
Apparent volume of distribution (Vz/f) for single-dose application (Period 1)
Time frame: 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
Mean residence time (MRT) for single-dose application (Period 1)
Time frame: 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
Terminal half-life (t½) for multiple-dose application
Time frame: 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.
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.
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.
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
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
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
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
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
Apparent total body clearance (CL/F) for multiple-dose application (Period 2)
Time frame: 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
Apparent volume of distribution (Vz/f) for multiple-dose application (Period 2)
Time frame: 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
Mean residence time (MRT) for multiple-dose application (Period 2)
Time frame: 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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
Derived from this study: PubMed 30098648Liu Y, Tomlinson B, Guo J, Asgharnejad M, Bauer L, Surmann E, Guo X, Elshoff JP. Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects. Clin Ther. 2018 Jul;40(7):1108-1121.e8. doi: 10.1016/j.clinthera.2018.05.009.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rotigotine, Period 1 and Rotigotine, Period 2 in people with Healthy, run by UCB Pharma at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma concentrations of unconjugated Rotigotine for single-dose application (Period 1) (time frame: Period 1; Day 1 to Day 3 of study). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01675024, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.