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Trial registered on ANZCTR


Registration number
ACTRN12613001057774
Ethics application status
Approved
Date submitted
11/09/2013
Date registered
23/09/2013
Date last updated
18/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of IPX203
Scientific title
IPX203-B13-02:Pharmacokinetics of IPX203 and Levodopa formulations in healthy volunteers
Secondary ID [1] 283160 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 290015 0
Condition category
Condition code
Neurological 290398 290398 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IPX203 will be administered in a single-center, open-label, randomized, single-dose, 5-sequence, 5-treatment crossover study in healthy male adults. The treatment periods will be separated by a washout period of at least 7 days. All subjects will receive the following 5 treatments in a randomized sequence. All treatments will be administered with 240 mL of water to subjects in the fasted state.
Treatment A comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C0019, C0022 and 2 tablets of carbidopa.
Treatment B comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C0019, C0021 and 2 tablets of carbidopa.
Treatment C comprises 3 capsules and 2 tablets: 1 capsule of investigational formulations C0017, C0020, C0021 and 2 tablets of carbidopa.
Treatment D comprises 3 capsules: 1 capsule of investigational formulations C0013, C0016 and C0021.
Treatment E comprises 1 tablet of Stalevo 100. Treatment E comprises 1 tablet of Stalevo 100.
Treatment A regimen contains a total dose of 280mg Levodopa, 250 mg Entacapone and 50 mg of Carbidopa.
Treatment B and C regimens each contain a total dose of 280mg equivalent Levodopa and 400 mg Entacapone formulated with different release characteristics, 50 mg of Carbidopa.
Treatment D regimen contains a total dose of 256mg equivalent Levodopa, 400 mg Entacapone and 50 mg of Carbidopa.
During each treatment period, subjects will remain at the clinical facility from the evening before dosing until approximately 8 h postdose for observation and PK sampling.
Intervention code [1] 287890 0
Treatment: Drugs
Comparator / control treatment
Treatment E: 1 tablet of Stalevo 100, for a total dose of Levodopa 100 mg, Carbidopa 25 mg, and Entacapone 200 mg
Control group
Active

Outcomes
Primary outcome [1] 290423 0
Pharmacokinetics
Timepoint [1] 290423 0
Whole blood samples will be obtained within 1 hour predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, and 8 hours postdose.
Secondary outcome [1] 304497 0
Safety
Timepoint [1] 304497 0
Any AE that emerges from the time the subject signs the ICF until Study Exit will be recorded and reported. Additional safety parameters (laboratory tests, 12-lead ECG, physical exams, and vital signs), and related information (demographics, concomitant medications) are to be recorded.

The more common adverse reactions seen with carbidopa/levodopa treatment include dyskinesias including, choreiform, dystonic and other involuntary movements, muscle twitching, eye twitching involuntary and nausea.
Other common reactions include mental changes, including paranoid ideation and psychotic episodes; depression, with or without development of suicidal tendencies; and cognitive dysfunction. The most frequent adverse reactions seen with entacapone treatment include nausea, vomiting, abdominal pain, constipation and diarrhoea. Urine may be discoloured reddish-brown by entacapone but this is a harmless phenomenon. Entacapone in association with levodopa has been associated with isolated episodes of excessive daytime somnolence and sudden sleep onset. Isolated cases of rhabdomyolysis have been reported. As this study drug is new, it is unknown what all of the possible side effects may be and there may be unknown risks. For a more complete list of possible side effects please ask the study doctor.

Eligibility
Key inclusion criteria
Healthy males between 18 years and 65 years of age inclusive at the time of informed consent.
Minimum age
18 Years
Maximum age
65 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of a clinically significant disorder involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s), or psychiatric disease (as determined by the Investigator)
History of peptic ulcer disease or surgical procedure of the stomach, the small intestine, or the large intestine
History of glaucoma
Suspicious skin lesions or history of melanoma
History of neuroleptic malignant syndrome (NMS) or nontraumatic rhabdomyolysis
Subject has smoked or used tobacco products or nicotine products (patches, gums, etc.) within 60 days prior to Period 1 dosing; subjects does not agree to abstain from tobacco or nicotine products throughout the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1489 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 287914 0
Commercial sector/Industry
Name [1] 287914 0
Impax Laboratories, Inc
Address [1] 287914 0
30831 Huntwood Avenue,
Hayward, CA 94544
Country [1] 287914 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Impax Laboratories, Inc. Acting through its Impax Pharmaceuticals Division
Address
31047 Genstar Road
Hayward, CA 94544
Country
United States of America
Secondary sponsor category [1] 286642 0
None
Name [1] 286642 0
Address [1] 286642 0
Country [1] 286642 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289847 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 289847 0
71 Anzac Highway
Ashford, SA 5035
Ethics committee country [1] 289847 0
Australia
Date submitted for ethics approval [1] 289847 0
25/09/2013
Approval date [1] 289847 0
28/10/2013
Ethics approval number [1] 289847 0
2013-09-513

Summary
Brief summary
The objective of Study IPX203-B13-02 is to characterize the pharmacokinetics of IPX203 and levodopa formulations in healthy subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42742 0
Dr Sepehr Shakib
Address 42742 0
CMAX, a division of IDT Australia Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 42742 0
Australia
Phone 42742 0
+61 08 8222-4638
Fax 42742 0
Email 42742 0
sepehr.shakib@health.sa.gov.au
Contact person for public queries
Name 42743 0
Prof Cmax
Address 42743 0
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 42743 0
Australia
Phone 42743 0
1800 150 433
Fax 42743 0
Email 42743 0
cmax@cmax.com.au
Contact person for scientific queries
Name 42744 0
Dr Sepehr Shakib
Address 42744 0
CMAX, a division of IDT Australia Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 42744 0
Australia
Phone 42744 0
+61 08 8222-4638
Fax 42744 0
Email 42744 0
sepehr.shakib@health.sa.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary