Healthy VolunteersPhase 1NCT00957944

Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

A Phase 1 study testing rotigotine transdermal patch (Neupro®) in people with Healthy Volunteers, run by UCB Pharma at 1 site in Germany.

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

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: rotigotine transdermal patch (Neupro®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteGermany
Study dates: Jul 2009to Aug 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

healthy, white, male volunteers between 18 and 55 years of age (inclusive)
BMI between 19 and 28 kg/m² (inclusive)

Who cannot join

previous participation in a clinical study with Rotigotine
history or current condition of epilepsy and/or seizures
known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations

Show all 10Show fewer

positive HIV, hepatitis B or C test or positive alcohol or drug test
relevant hepatic or renal dysfunction
intake of medication that might interfere with the test drug within 2 weeks prior to dosing
thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Neuss, North Rhine-Westphalia

Other trials in Germany

About this study

Official title: Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5 mg/10 cm^2) From 2 Different Manufacturing Sites.

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.

Conditions: Healthy Volunteers
Being tested: rotigotine transdermal patch (Neupro®)
Keywords: Rotigotine, Neupro®

What participants receive

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

rotigotine transdermal patch (Neupro®)Drug
Also called Neupro®
Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours

Study groups in NCT00957944
Study group	Role	What they receive
Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	Experimental	Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days Receives: Drug: rotigotine transdermal patch (Neupro®)
Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)	Experimental	Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days Receives: Drug: rotigotine transdermal patch (Neupro®)

What is being measured

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

AUC(0-tz) of Unconjugated Rotigotine
The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Cmax of Unconjugated Rotigotine
The Cmax is the maximum plasma concentration.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-∞) of Unconjugated Rotigotine
The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Secondary outcomes (12)

AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine
The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-tz) Norm (BW) of Unconjugated Rotigotine
The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-∞) Norm (Apparent Dose)
The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-∞) Norm (BW)
The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine
The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Cmax,Norm (BW) of Unconjugated Rotigotine
The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Tmax of Unconjugated Rotigotine
The tmax is the time to reach a maximum plasma concentration after patch application.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
MRT of Unconjugated Rotigotine
The MRT is the mean residence time.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
λz of Unconjugated Rotigotine
The λz is the rate constant of elimination.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
t1/2 of Unconjugated Rotigotine
The t1/2 is the terminal half- life.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
CL/f of Unconjugated Rotigotine
The CL/f is the apparent total body clearance.
Measured: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Apparent Dose
Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.
Measured: 48 hours

Timeline

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

Jul 2009Aug 2009

First posted13 Aug 2009 (estimated)
Study startJul 2009
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00957944
Sponsor's protocol ID: SP0957
Status last verified: Apr 2012
First submitted: 11 Aug 2009
Last updated: 27 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5 mg/10 cm^2) From 2 Different Manufacturing Sites.
ClinicalTrials.gov ID: NCT00957944
Acronym / sponsor ID: SP0957
Conditions: Healthy Volunteers
Keywords: Rotigotine, Neupro®
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 13 Aug 2009 (estimated)
Results: Posted 22 Sep 2010

Clinical summary

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

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	Experimental	Drug: rotigotine transdermal patch (Neupro®)Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days
Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)	Experimental	Drug: rotigotine transdermal patch (Neupro®)Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

healthy, white, male volunteers between 18 and 55 years of age (inclusive)
BMI between 19 and 28 kg/m² (inclusive)

Key exclusion criteria (10 listed)

previous participation in a clinical study with Rotigotine
history or current condition of epilepsy and/or seizures
known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease

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 transdermal patch (Neupro®)Also: Neupro®Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours	Drug	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND), Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)

Primary outcome

AUC(0-tz) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.
Cmax of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The Cmax is the maximum plasma concentration.
AUC(0-∞) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity

12 secondary outcomes

AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-tz) Norm (BW) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-∞) Norm (Apparent Dose)
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
AUC(0-∞) Norm (BW)
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Cmax,Norm (BW) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Tmax of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
MRT of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
λz of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
t1/2 of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
CL/f of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
Apparent Dose
Time frame: 48 hours

Results and safety

Results posted to the registry on 22 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	20	20
Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)	20	19

Primary outcome: AUC(0-tz) of Unconjugated Rotigotine

Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.. Mean (Standard Deviation). Unit: (ng/ mL)*h

Measure	Treatment A (Test: PR 2.1.1 WCL) n = 38	Treatment B (Reference: PR 2.1.1 AND) n = 38
Value	4.3899 (1.7959)	4.4255 (2.3969)

Treatment A (Test: PR 2.1.1 WCL) vs Treatment B (Reference: PR 2.1.1 AND): ratio of geometric LS- Means: 1.0302 (90% CI 0.9693 to 1.0951), ANOVA

Population analysed: Pharmacokinetic Set (PKS)

Primary outcome: Cmax of Unconjugated Rotigotine

Measure	Treatment A (Test: PR 2.1.1 WCL) n = 38	Treatment B (Reference: PR 2.1.1 AND) n = 38
Value	0.21103 (0.08827)	0.20386 (0.10194)

Treatment A (Test: PR 2.1.1 WCL) vs Treatment B (Reference: PR 2.1.1 AND): ratio of geometric LS- Means: 1.0571 (90% CI 0.9903 to 1.1284), ANOVA

Population analysed: Pharmacokinetic Set (PKS)

Primary outcome: AUC(0-∞) of Unconjugated Rotigotine

Measure	Treatment A (Test: PR 2.1.1 WCL) n = 38	Treatment B (Reference: PR 2.1.1 AND) n = 38
Value	4.51237 (1.80709)	4.55159 (2.42524)

Treatment A (Test: PR 2.1.1 WCL) vs Treatment B (Reference: PR 2.1.1 AND): ratio of geometric LS- Means: 1.0289 (90% CI 0.9714 to 1.0899), ANOVA

Population analysed: Pharmacokinetic Set (PKS)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A (Test: PR 2.1.1 WCL)	0 of 39 (0%)	5 of 39 (12.8%)	Not reported
Treatment B (Reference: PR 2.1.1 AND)	0 of 40 (0%)	6 of 40 (15%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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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.

UCB Clinical Trial Call center study director

+1 877 822 9493 (UCB)

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 transdermal patch (Neupro®) in people with Healthy Volunteers, run by UCB Pharma at 1 site in Germany.

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 10 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 27 Oct 2014. 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 Germany. 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?

Yes. Results are posted in the registry (first posted 22 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

AUC(0-tz) of Unconjugated Rotigotine (time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.). The study lists 3 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 NCT00957944.

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 27 Oct 2014.