Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001073796
Ethics application status
Approved
Date submitted
24/09/2013
Date registered
25/09/2013
Date last updated
22/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Pharmacokinetics of IPX233 Formulations in Healthy Volunteers
Scientific title
IPX233-B13-01:Evaluation of the Pharmacokinetics of IPX233 Formulations in Healthy Volunteers
Secondary ID [1] 283252 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 290127 0
Condition category
Condition code
Neurological 290510 290510 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An open-label, randomized, 4-sequence, 4-treatment, single-dose crossover study with at least 7 days of washout between each treatment period.
Treatment A: 1 capsule of IPX233-C0001 2 mg
Treatment B: 1 capsule of IPX233-C0002 2 mg
Treatment C: 1 tablet of IPX233-T0001 2 mg
Treatment D: 1 tablet of IPX233-T0002 2 mg


Postdose:
Measure BP (blood pressure), HR(heart rate) and RR(respiratory rate) at approximately 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours after dosing in each treatment period (subject should be supine for at least 5 minutes prior to measurements)
Conduct 12-lead ECG at approximately 2, 6 and 24 hours postdosing in each treatment period
Intervention code [1] 287985 0
Treatment: Drugs
Comparator / control treatment
Treatment D: 1 tablet of IPX233-T0002 2 mg
Control group
Active

Outcomes
Primary outcome [1] 290531 0
Pharmacokinetics
Timepoint [1] 290531 0
A total of 15 blood samples (6 mL each) will be collected at the following timepoints after administration of IPX233 in each treatment period to quantify IPX233 and potential metabolites in plasma: Predose (up to 60 minutes prior to dosing), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours postdose.
Secondary outcome [1] 304745 0
Safety
Timepoint [1] 304745 0
12-lead electrocardiogram (ECGs), clinical laboratory tests, vital signs, adverse events (AEs), and concomitant medications will be evaluated over the course of the study. Physical examinations will be performed at Screening and at Study Exit. ECGs will be evaluated prior to the administration of IPX233 and after dosing in each treatment period.
Postdose:
Measure BP (blood pressure), HR(heart rate) and RR(respiratory rate) at approximately 1, 2, 4, 6, 12, 24, 48, 72, and 96 hours after dosing in each treatment period (subject should be supine for at least 5 minutes prior to measurements)
Conduct 12-lead ECG at approximately 2, 6 and 24 hours postdosing in each treatment period

The possible adverse events (e.g. dry mouth, insomnia, constipation, etc.)

Eligibility
Key inclusion criteria
Healthy volunteers between the ages of 18 and 55 years of age (inclusive) at the time of informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of drug or alcohol addiction or abuse within the last 5 years.
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.
History of or clinical signs of glaucoma, benign prostatic hypertrophy or urinary retention.
History of or clinical signs of any form of epilepsy or seizures.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2013
Actual
6/12/2013
Date of last participant enrolment
Anticipated
Actual
14/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1532 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 287993 0
Commercial sector/Industry
Name [1] 287993 0
Impax Laboratories, Inc
Country [1] 287993 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Impax Pharmaceuticals,A Division of Impax Laboratories, Inc.
Address
31047 Genstar Road
Hayward, CA 94544
Country
United States of America
Secondary sponsor category [1] 286711 0
None
Name [1] 286711 0
Address [1] 286711 0
Country [1] 286711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289918 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 289918 0
71 Anzac Highway
Ashford, SA 5035
Ethics committee country [1] 289918 0
Australia
Date submitted for ethics approval [1] 289918 0
07/10/2013
Approval date [1] 289918 0
19/11/2013
Ethics approval number [1] 289918 0
2013-10-537

Summary
Brief summary
To characterize the pharmacokinetics (PK) of three IPX233 formulations (C0001, C0002, T0001) compared with one IPX233 formulation (T0002).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43086 0
Dr Sepehr Shakib
Address 43086 0
CMAX, a division of IDT Australia Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 43086 0
Australia
Phone 43086 0
+61 08 8222-4638
Fax 43086 0
Email 43086 0
[email protected]
Contact person for public queries
Name 43087 0
Cmax
Address 43087 0
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 43087 0
Australia
Phone 43087 0
1800 150 433
Fax 43087 0
Email 43087 0
[email protected]
Contact person for scientific queries
Name 43088 0
Sepehr Shakib
Address 43088 0
CMAX, a division of IDT Australia Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 43088 0
Australia
Phone 43088 0
+61 08 8222-4638
Fax 43088 0
Email 43088 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.