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Trial registered on ANZCTR


Registration number
ACTRN12614000330640
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
27/03/2014
Date last updated
17/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Pharmacokinetics and Safety of Dihydroergotamine Administered Via Two Intranasal Delivery Devices
Scientific title
IPX234-B13-01: Evaluation of the Pharmacokinetics and Safety of Dihydroergotamine Administered Via Two Intranasal Delivery Devices in healthy volunteers
Secondary ID [1] 284299 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 291430 0
Condition category
Condition code
Neurological 291797 291797 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Objective: To compare the pharmacokinetics and safety of dihydroergotamine (DHE) delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator.

Methods: Single-center, open-label, randomized, single-dose, 2-sequence, 2-treatment crossover study in healthy adults. The 2 treatment periods will be separated by a washout period of at least 5 days.

Investigational product, dosage and mode of administration:
IPX234. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the investigational device which is being developed to optimize the delivery of drugs to the upper nasal cavity in order to improve the distribution profile of central nervous system (CNS) targeting drugs.


Reference product, dosage and mode of administration:
Migranal (dihydroergotamine mesylate, USP) Nasal Spray. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the Migranal nasal spray applicator.
Traditional nasal pumps, such as the Migranal Nasal Spray applicator, typically only deliver a small fraction of drug to upper nasal cavity.
Intervention code [1] 289001 0
Treatment: Devices
Intervention code [2] 289060 0
Treatment: Drugs
Comparator / control treatment
Migranal (dihydroergotamine mesylate, USP) Nasal Spray. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the Migranal nasal spray applicator.
Control group
Active

Outcomes
Primary outcome [1] 291720 0
Pharmacokinetics
Timepoint [1] 291720 0
In each treatment period, blood samples will be collected predose and at the following times postdose: 5, 10, 15, 30, 60, 90 minutes; 2, 3, 4, 6, 10, 16, 24 h.
Secondary outcome [1] 307347 0
Safety
Timepoint [1] 307347 0
Adverse events, 12-lead electrocardiograms, vital signs, and concomitant medications will be evaluated over the course of the study. Physical examinations and clinical laboratory tests will be performed at Screening and at Study Exit. A nasal mucosal exam will be performed at Screening; and at Check-in, at predose, and at approximately 1 hour postdose in each treatment period.

Eligibility
Key inclusion criteria
Healthy male and female subjects between 18 years and 40 years of age inclusive at the time of Screening
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of a clinically significant disorder including acute or chronic infections, or a malignant neoplasm, and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators

An upper respiratory tract infection or any other acute illness, including active allergic rhinitis, at Screening or at Check-in for each treatment period that the investigator believes may interfere with the administration, nasal retention, or absorption of study drug; or any prior medical conditions that, in the opinion of the Investigator, would interfere or modify the nasal administration, retention, or absorption of study drug

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
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

Funding & Sponsors
Funding source category [1] 288913 0
Commercial sector/Industry
Name [1] 288913 0
Impax Laboratories, Inc
Address [1] 288913 0
30831 Huntwood Avenue,
Hayward, CA94544
Country [1] 288913 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Impax Laboratories, Inc
Address
30831 Huntwood Avenue
Hayward, CA94544
Country
United States of America
Secondary sponsor category [1] 287621 0
None
Name [1] 287621 0
Address [1] 287621 0
Country [1] 287621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290743 0
The Alfred
Ethics committee address [1] 290743 0
The Alfred
Office of Ethics and Research Governance
Ground Floor, Linay Pavilion
Alfred Hospital, Commercial Rd, Melbourne, Victoria, AUS 3004
Ethics committee country [1] 290743 0
Australia
Date submitted for ethics approval [1] 290743 0
24/03/2014
Approval date [1] 290743 0
02/05/2014
Ethics approval number [1] 290743 0

Summary
Brief summary
To compare the pharmacokinetics and safety of dihydroergotamine delivered via 2 nasal spray devices: the investigational device versus the Migranal nasal spray applicator.

Methods: Single-center, open-label, randomized, single-dose, 2-sequence, 2-treatment crossover study in healthy adults. The 2 treatment periods will be separated by a washout period of at least 5 days.

Investigational product, dosage and mode of administration:
IPX234. 1 mg DHE solution (1 spray in each nostril; 0.5 mg DHE per spray) administered intranasally via the investigational device.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 47034 0
Dr Jason Lickliter
Address 47034 0
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, Australia, 3004
Country 47034 0
Australia
Phone 47034 0
61 3 9076 8960
Fax 47034 0
Email 47034 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 47035 0
Dr Jason Lickliter
Address 47035 0
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, Australia, 3004
Country 47035 0
Australia
Phone 47035 0
61 3 9076 8960
Fax 47035 0
Email 47035 0
j.lickliter@nucleusnetwork.com.au
Contact person for scientific queries
Name 47036 0
Dr Jason Lickliter
Address 47036 0
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, Australia, 3004
Country 47036 0
Australia
Phone 47036 0
61 3 9076 8960
Fax 47036 0
Email 47036 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