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Trial registered on ANZCTR


Registration number
ACTRN12613001097730
Ethics application status
Approved
Date submitted
1/10/2013
Date registered
1/10/2013
Date last updated
23/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Pharmacokinetics of IPX237 Formulations in Healthy Volunteers
Scientific title
Evaluation of the Pharmacokinetics of IPX237 Formulations in Healthy Volunteers
Secondary ID [1] 283323 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 290215 0
Condition category
Condition code
Mental Health 290605 290605 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An single-center, open-label, randomized, single-dose, 4-sequence, 4-treatment crossover study with at least 5 days of washout between dosing in each treatment period. Subjects will receive the following investigational treatments under fasted conditions in a randomized sequence: Treatment A: 1 capsule of IPX237-C0001 30 mg Treatment B: 1 capsule of IPX237-C0002 30 mg Treatment C: sublingual paste of IPX237-L0001 30 mg Treatment D: 15 mg esketamine (free base equivalent) infused IV over 40 minutes Postdose: The subject should be evaluated at 32 hours postdose to determine that they are medically stable. The subject should be driven home by a responsible adult
Intervention code [1] 288045 0
Treatment: Drugs
Comparator / control treatment
Treatment D: 15 mg esketamine (free base equivalent) infused IV over 40 minutes
Control group
Active

Outcomes
Primary outcome [1] 290619 0
Pharmacokinetics
Timepoint [1] 290619 0
During each treatment period, blood samples will be collected for measurement of esketamine and potential metabolites in plasma at the following times: within 60 minutes predose, and postdose at 10, 20, 30, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Saliva samples will be collected at Check-in, and postdose at 40 minutes, 6 hours, 12 hours, and 24 hours for potential analysis of esketamine and its metabolites.
Secondary outcome [1] 304920 0
Safety
Timepoint [1] 304920 0
Three serial 12-lead electrocardiograms (ECG), 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. Three serial ECGs will be evaluated in each treatment period at Screening, predose, and at 45 minutes, 8, and 24 hours postdose. Telemetry will be obtained from 1 hour predose to 8 hours postdose. Vital signs will be measured in each period as specified. Psychiatric effects and dissociative symptoms will be assessed at specified times postdose by the Brief Psychiatric Rating Scale (BPRS) and dissociative symptoms will be gauged by the Clinician-Administered Dissociative States Rating Scale (CADSS).

Eligibility
Key inclusion criteria
Healthy volunteers between the ages of 18 and 55 years of age inclusive and weighing at least 60 kg at the time of informed consent.
Minimum age
18 Years
Maximum age
55 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.
History of psychosis in self or family.
History of or clinical signs of glaucoma.
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
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] 1566 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 288057 0
Commercial sector/Industry
Name [1] 288057 0
Impax Laboratories, Inc.
Address [1] 288057 0
30831 Huntwood Avenue
Hayward, CA94544
Country [1] 288057 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] 286780 0
None
Name [1] 286780 0
Address [1] 286780 0
Country [1] 286780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289982 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 289982 0
71 Anzac Highway
Ashford, SA 5035
Ethics committee country [1] 289982 0
Australia
Date submitted for ethics approval [1] 289982 0
09/10/2013
Approval date [1] 289982 0
20/11/2013
Ethics approval number [1] 289982 0
2013-10-538

Summary
Brief summary
To characterize the pharmacokinetics (PK) of esketamine hydrochloride from 2 oral and 1 sublingual formulations of IPX237 compared to that from intravenous esketamine hydrochloride.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43366 0
Dr Sepehr Shakib
Address 43366 0
CMAX, a division of IDT Australia Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 43366 0
Australia
Phone 43366 0
+61 08 8222-4638
Fax 43366 0
Email 43366 0
sepehr.shakib@health.sa.gov.au
Contact person for public queries
Name 43367 0
Prof Cmax
Address 43367 0
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 43367 0
Australia
Phone 43367 0
1800 150 433
Fax 43367 0
Email 43367 0
cmax@cmax.com.au
Contact person for scientific queries
Name 43368 0
Dr Sepehr Shakib
Address 43368 0
CMAX, a division of IDT Australia Limited
Level 5 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country 43368 0
Australia
Phone 43368 0
+61 08 8222-4638
Fax 43368 0
Email 43368 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