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Trial registered on ANZCTR


Trial ID
ACTRN12614000518662
Ethics application status
Approved
Date submitted
7/05/2014
Date registered
15/05/2014
Date last updated
12/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the pharmacokinetics and safety of multiple once-daily doses of IPX233 in healthy adult volunteers
Scientific title
IPX233-B14-02: Evaluation of the pharmacokinetics and safety of multiple once-daily doses of IPX233 in healthy adult volunteers
Secondary ID [1] 284553 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHA) 291817 0
Condition category
Condition code
Neurological 292181 292181 0 0
Other neurological disorders
Mental Health 292244 292244 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single-blind, placebo-controlled, fixed-sequence study.

Subjects will remain housed in the study center through the first 14 nights and receive the following treatments orally with approximately 240 mL of room-temperature water in a fixed sequence:

Days 1-2: One placebo capsule once-daily taken immediately before a standard breakfast.
Day 3:One IPX233 ER C0003 capsule 4 mg taken immediately before a standard breakfast.
Day 4:One placebo capsule taken immediately before a standard breakfast.
Days 5-6-7-8-9-10-11:One IPX233 ER C0003 capsule 4 mg once-daily taken immediately before a standard breakfast.
Days 12-13:One placebo capsule once-daily taken immediately before a standard breakfast.
Intervention code [1] 289320 0
Treatment: Drugs
Comparator / control treatment
placebo capsule contains the same excipients used in study drug such as Microcrystalline Cellulose, Dibasic Calcium Phosphate.
Control group
Placebo

Outcomes
Primary outcome [1] 292060 0
Pharmacokinetics
Timepoint [1] 292060 0
Serial blood samples (6 mL each) will be collected at the following timepoints relative to the time of study drug administration on each day:

Day 1: Pre-dose (up to 30 min before dosing), 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 16 hours postdose
Day 2: Pre-dose (up to 30 min before dosing) and 12 hours postdose
Day 3: Pre-dose (up to 30 min before dosing), 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 16 hours postdose
Day 4: Pre-dose (up to 30 min before dosing) and 12 hours postdose
Day 5:Pre-dose (up to 30 min before dosing), 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 16 hours postdose
Days 6-7-8-9-10:Pre-dose (up to 30 min before dosing)
Day 11:Pre-dose (up to 30 min before dosing), 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 16 hours postdose
Day 12: Pre-dose (up to 30 min before dosing) and 12 hours postdose
Day 13: Pre-dose (up to 30 min before dosing) and 12 hours postdose
Day 14: Approximately same time as when subject was dosed
Day 15: Approximately same time as when subject was dosed (if subject is required to return for safety assessments)
Day 16: Approximately same time as when subject was dosed (if subject is required to return for safety assessments)
Day 17: Approximately same time as when subject was dosed (if subject is required to return for safety assessments)
Secondary outcome [1] 308111 0
Safety
Timepoint [1] 308111 0
12-lead electrocardiogram (ECGs), clinical laboratory tests, vital signs including orthostatic heart rate and blood pressure, adverse events (AEs), and concomitant medications will be evaluated over the course of the study from screening to Study Exit at Day 17. Physical examinations will be performed at Screening and at Study Exit. 12-lead ECGs will be evaluated prior to the administration of IPX233 and after dosing. Vital signs including standing orthostatic heart rate and blood pressure will be measured as specified in the Schedule of Assessments.

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

Eligibility
Key inclusion criteria
Healthy volunteers between the ages of 18 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
Any history of drug or alcohol addiction or abuse.
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, musculoskeletal, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, neurologic, or psychiatric (including bipolar disorder), as determined by Clinical Investigators.
History of or clinical signs of narrow angle 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
Non-randomised 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
Withdrawn
Reason for early stopping/withdrawal
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

Funding & Sponsors
Funding source category [1] 289182 0
Commercial sector/Industry
Name [1] 289182 0
Impax Laboratories, Inc
Address [1] 289182 0
30831 Huntwood Avenue Hayward, CA 94544
Country [1] 289182 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] 287851 0
None
Name [1] 287851 0
Address [1] 287851 0
Country [1] 287851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290962 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 290962 0
71 Anzac Highway Ashford, SA 5035
Australia
Ethics committee country [1] 290962 0
Australia
Date submitted for ethics approval [1] 290962 0
11/06/2014
Approval date [1] 290962 0
22/07/2014
Ethics approval number [1] 290962 0

Summary
Brief summary
Study IPX233-B14-02 will evaluate the placebo-controlled safety and the PK of repeated once-daily doses of a 4 mg dose of an ER formulation of IPX233 in healthy adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47846 0
Dr Sepehr Shakib
Address 47846 0
CMAX, a division of IDT Australia Limited Level 5 East Wing Royal Adelaide Hospital North Terrace Adelaide, SA 5000
Country 47846 0
Australia
Phone 47846 0
+61 08 8222-4638
Fax 47846 0
Email 47846 0
sepehr.shakib@health.sa.gov.au
Contact person for public queries
Name 47847 0
Mr Teo Franic
Address 47847 0
CMAX, a division of IDT Australia Limited Level 5 East Wing Royal Adelaide Hospital North Terrace Adelaide, SA 5000
Country 47847 0
Australia
Phone 47847 0
+61 8 8222 3923
Fax 47847 0
Email 47847 0
Teo.franic@cmax.com.au
Contact person for scientific queries
Name 47848 0
Dr Sepehr Shakib
Address 47848 0
CMAX, a division of IDT Australia Limited Level 5 East Wing Royal Adelaide Hospital North Terrace Adelaide, SA 5000
Country 47848 0
Australia
Phone 47848 0
+61 08 8222-4638
Fax 47848 0
Email 47848 0
sepehr.shakib@health.sa.gov.au