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Trial registered on ANZCTR


Registration number
ACTRN12612000946819
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
4/09/2012
Date last updated
24/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A first-in-man study to compare an investigational ropinirole transdermal patch formulation with a ropinirole oral tablet (Requip [Registered Trademark] XL [Trademark]) in healthy volunteers.
Scientific title
An Exploratory, Open-Label, Single- and Repeat-Dose, Randomized, Two-Period, Cross-Over Study in Healthy Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of a Transdermal Patch Formulation of Ropinirole Compared to Oral Ropinirole
Secondary ID [1] 281137 0
Nil
Universal Trial Number (UTN)
U1111-1134-1261
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 287308 0
Condition category
Condition code
Neurological 287643 287643 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions being used include the Ropinirole transdermal patch - 8 cm2 transdermal patch, containing 3.84 mg of ropinirole and targeted to deliver 2 mg with each daily application and Requip[Registered Trademark] XL[Trademark] (ropinirole extended release tablets, 2 mg) - 2mg oral tablet.

The study will be conducted in 24 healthy volunteers divided into 2 treatment groups that will be run in parallel (at the same time).

Group 1: will receive a single ropinirole transdermal patch application and a single Requip[Registered Trademark] XL[Trademark] tablet (or vice-versa) separated by a 3-day washout period

Group 2: will receive 5 consecutive daily ropinirole transdermal patches and 5 consecutive daily Requip[Registered Trademark] XL[Trademark] tablets (or vice-versa) separated by a 3-day washout period.
Intervention code [1] 285597 0
Treatment: Drugs
Comparator / control treatment
Requip[Registered Trademark] XL[Trademark] (ropinirole extended release tablets, 2 mg) - 2mg oral tablet.
Control group
Active

Outcomes
Primary outcome [1] 287892 0
The primary objective of this study is to assess the pharmacokinetic (PK) profiles of ropinirole following single and repeat (5) administrations of the Ropinirole Transdermal Patch compared with single and repeat doses of oral Requip XL extended release tablets.
Timepoint [1] 287892 0
Group 1: PK sampling will start on each treatment day (ie, Days 1 and 5) according to the following schedule: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, and 48 h after dosing (with the transdermal patch or the oral tablet).

Group 2: Based on randomization, the PK sampling schedule is as follows:
Ropinirole Transdermal Patch:
Day 1 or 9: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 h after application of the first patch
Days 2-4 or Days 10-12: predose, and 3, 6, and 9 h after application
Day 5 or 13: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, and 48 h after application of the last (5th) patch
Requip XL tablet:
Days 1-4 or Days 9-12: predose
Day 5 or 13: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, and 48 h after dosing
Secondary outcome [1] 298994 0
To assess safety and tolerability of the Ropinirole Transdermal Patch including assessment of skin irritation using a modified Draize scale.
Timepoint [1] 298994 0
Skin irritation will be assessed at 1 and 24 h after removal of each patch.
Secondary outcome [2] 298995 0
To assess adhesion of the Ropinirole Transdermal Patch using observations that will be quantified using the scoring system described in the Protocol (Patch Adhesion Scale).
Timepoint [2] 298995 0
Patch adhesion will be assessed at 6, 12, and 18 h after application and immediately prior to removal of each patch.

Eligibility
Key inclusion criteria
1. Healthy male or female subjects 18 to 40 years of age, inclusive.
2. Subjects must be non-smokers, as defined by not smoking for at least 1 year prior to screening.
3. Body mass index (BMI) within the range of 18 to 29 kg/m2, inclusive, and a minimum weight of at least 50 kg.
4. Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair or skin allergies and sensitivities that may compromise the subject’s ability to wear the investigational product at any of the application sites for the specified duration of treatment.
5. Female subjects of childbearing potential must be practicing abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month prior to dosing and for at least 30 days after the last study drug administration, or until their next menstrual period.
6. Female subjects must have a negative serum pregnancy test prior to dosing.
7. Must be able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
8. Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
9. Must be willing and able to abide by all study requirements and restrictions.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A history or presence of drug or alcohol dependence (excluding caffeine), including subjects who have ever been in a drug rehabilitation program based on medical history.
2. Clinically significant abnormalities as judged by the investigator or designee and determined by physical examination, medical history, 12-lead electrocardiogram (ECG), vital signs, laboratory values including serum kidney and liver function tests.
3. Presence of postural hypotension (determined through examination by the investigator or designee), or recent history of severe dizziness or fainting due to postural hypotension on standing.
4. Subjects with a history of seizures, asthma or obstructive pulmonary disease.
5. Presence or history of a psychiatric disorder, organic brain disorder, or seizure disorder deemed clinically significant by the investigator or designee.
6. Presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including ulcers or gastrointestinal bleeding), endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results.
7. Abnormality (eg, scar, tattoo) or unhealthy skin (eg, burns, wounds) at the application site, according to examination by the investigator at screening or admission to the treatment period of the study.
8. An existing chronic skin disease or history of skin disease at the application site within the 30 days prior to screening.
9. Use of any drugs containing estrogens within 30 days prior to first drug administration and throughout the study.
10. Use of any medications that are inhibitors or inducers of CYP1A2 or CYP3A4 within 14 days prior to first drug administration and throughout the study.
11. Use of any prescription medications or natural health products (except vitamin or mineral supplements, or acceptable forms of birth control) within 14 days prior to first drug administration or throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity, or compromise the safety of the subject.
12. Use of a non-prescription drug within 7 days prior to the first drug administration. Subjects who have taken over-the-counter medication may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity, or compromise the safety of the subject.
13. Positive urine drug screen prior to dosing.
14. Positive alcohol test prior to dosing.
15. Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration.
16. History of allergy or hypersensitivity to ropinirole, ropinirole hydrochloride or to ergot or non-ergoline derivatives, related drugs, any of the drug excipients or other drug product components, or to indelible ink.
17. Positive for Hepatitis B, Hepatitis C, or the human immunodeficiency virus (HIV).
18. Donation of blood or loss of blood (> 100 mL) within 30 days prior to the first administration of study drug.
19. Subject has a personal responsibility or already confirmed appointment(s) or court dates that would in any way prevent him/her from meeting the time commitments and visits required by the study.
20. Treatment with any investigational drug within 30 days prior to first study-drug administration.
21. A subject who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a randomized, open-label study. Within each treatment group, subjects will be randomized in a 1:1 ratio to one of two treatment sequences, as follows:
*Patch, 3-day washout, tablet
*Tablet, 3-day washout, patch
Study drug will not be blinded.

Upon confirmation of eligbility subjects will be assigned (by the PI) the next sequential randomisation number from the randomisation list which is held by the Pharmacist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (using a computerised sequence generation) to one of two treatment sequences in a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2012
Actual
27/09/2012
Date of last participant enrolment
Anticipated
Actual
27/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285918 0
Commercial sector/Industry
Name [1] 285918 0
Teikoku Pharma USA, Inc
Country [1] 285918 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
INCResearch Australia Pty Ltd
Address
124 Lipson Street
Port Adelaide SA 5015
Country
Australia
Secondary sponsor category [1] 284741 0
None
Name [1] 284741 0
Address [1] 284741 0
Country [1] 284741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287947 0
Bellberry Limited
Ethics committee address [1] 287947 0
Ethics committee country [1] 287947 0
Australia
Date submitted for ethics approval [1] 287947 0
20/07/2012
Approval date [1] 287947 0
23/08/2012
Ethics approval number [1] 287947 0
2012-07-951

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34652 0
Dr Andrew Redfern
Address 34652 0
Linear Clinical Research - Level 1, B Block, Hospital Avenue, Nedlands, Perth, 6009 Western Australia
Country 34652 0
Australia
Phone 34652 0
+61 8 6382 5100
Fax 34652 0
Email 34652 0
[email protected]
Contact person for public queries
Name 17899 0
Sally Johnsson
Address 17899 0
INC Research - Suite 1, Level 2, 924 Pacific Highway, Gordon, NSW 2072, Australia
Country 17899 0
Australia
Phone 17899 0
+61(0)2 8437 9237
Fax 17899 0
+61(0)2 8437 9299
Email 17899 0
[email protected]
Contact person for scientific queries
Name 8827 0
Kenneth D. Krantz, M.D., Ph.D
Address 8827 0
1718 Ringwood Ave
San Jose, CA 95131
Country 8827 0
United States of America
Phone 8827 0
+1-650-888-9639
Fax 8827 0
Email 8827 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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