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Trial registered on ANZCTR


Registration number
ACTRN12613000973718
Ethics application status
Approved
Date submitted
27/08/2013
Date registered
2/09/2013
Date last updated
22/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Pharmacokinetics of IPX231 (L0007, C0001) in Healthy Subjects
Scientific title
Evaluation of the Pharmacokinetics of IPX231 (L0007, C0001) in Healthy Subjects
Secondary ID [1] 283088 0
None
Universal Trial Number (UTN)
U1111-1147-2306
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 289923 0
Condition category
Condition code
Neurological 290297 290297 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IPX231 will be administered a single-center, open-label, randomized, single-dose, 4 sequence, 4 treatment crossover study. Treatments will be separated by at least a 7-day washout period. Subjects will remain at the clinical facility for approximately 24 hours during each of the 4 treatment periods.
Treatment A: IPX231-L0007 (solution) 0.25 mL administered sublingually via syringe.
Treatment B: IPX231-L0007 (solution) 0.25 mL administered sublingually via spray pump.
Treatment C: IPX231-C0001 (encapsulated powder) 34.2 mg administered sublingually by dispersion of powder.
Treatment D: Apomine Injection (0.2 mL of 10 mg apomorphine HCl/mL), containing 2.0 mg apomorphine HCl (1.76 mg apomorphine), administered subcutaneously per package insert instructions
Intervention code [1] 287803 0
Treatment: Drugs
Comparator / control treatment
A single dose of Apomine Injection (0.2 mL of 10 mg apomorphine HCl/mL) will be administered as one of the treatments in this open-label, randomized, single-dose, 4 sequence, 4 treatment crossover study.
Control group
Active

Outcomes
Primary outcome [1] 290329 0
Pharmacokinetics
Timepoint [1] 290329 0
During each treatment period, blood samples will be obtained within 1 hour predose, and at 5, 10, 20, 30, 40, 50 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose.
Secondary outcome [1] 304309 0
Adverse events (AEs), three serial 12-lead electrocardiograms (ECG), telemetry, physical exams, clinical laboratory test data, vital signs, and concomitant medications will be collected and evaluated over the course of the study.

AEs associated with IPX231 are expected to be similar to Apomine which include nausea, vomiting, drowsiness, somnolence, muscle pain and feeling faint.

AEs associated with Motilium include dry mouth, headache, nervousness, diarrhoea, nausea, heart burn, constipation and appetite disorders.
Timepoint [1] 304309 0
Throughout the course of the study.

Eligibility
Key inclusion criteria
Healthy adult subjects between 18 years and 45 years of age inclusive at the time of informed consent.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of a clinically significant disorder, as determined by the Investigator, involving bleeding or hematologic or cardiovascular system abnormalities, acute infections, respiratory, renal, gastrointestinal, immunologic, hepatic, reproductive, endocrine, or neurologic system(s); or psychiatric disease; or oral trauma or disease.

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)
VIC
Recruitment hospital [1] 1456 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 287844 0
Commercial sector/Industry
Name [1] 287844 0
Impax Laboratories, Inc.
Address [1] 287844 0
30831 Huntwood Avenue,
Hayward, CA 94544
Country [1] 287844 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Impax Laboratories, Inc.
Address
30831 Huntwood Avenue,
Hayward, CA 94544
Country
United States of America
Secondary sponsor category [1] 286572 0
None
Name [1] 286572 0
Address [1] 286572 0
Country [1] 286572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289784 0
The Alfred Ethics Committee
Ethics committee address [1] 289784 0
The Royal Prince Alfred Hospital
55 Commercial Rd.
Melbourne, Victoria 3004

Ethics committee country [1] 289784 0
Australia
Date submitted for ethics approval [1] 289784 0
23/01/2014
Approval date [1] 289784 0
18/02/2014
Ethics approval number [1] 289784 0

Summary
Brief summary
To compare the pharmacokinetics of three IPX231 formulations administered subcutaneously as well as a single IPX231 formulation (IPX231-L0007) administered sublingually by two different methods: instillation via syringe versus spray in healthy adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42406 0
Dr Jason Lickliter
Address 42406 0
Nucleus Network
89 Commercial Road
The Center for Commercial Studies
Melbourne, VIC 3000
Country 42406 0
Australia
Phone 42406 0
+61 03 9076 8906
Fax 42406 0
Email 42406 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 42407 0
Ms Emily Bingle
Address 42407 0
Nucleus Network
89 Commercial Road
The Center for Commercial Studies
Melbourne, VIC 3000
Country 42407 0
Australia
Phone 42407 0
+61 03 9076 3619
Fax 42407 0
Email 42407 0
e.bingle@nucleusnetwork.com.au
Contact person for scientific queries
Name 42408 0
Dr Jason Lickliter
Address 42408 0
Nucleus Network
89 Commercial Road
The Center for Commercial Studies
Melbourne, VIC 3000
Country 42408 0
Australia
Phone 42408 0
+61 03 9076 8906
Fax 42408 0
Email 42408 0
j.lickliter@nucleusnetwork.com.au

No information has been provided regarding IPD availability
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