Please note the ANZCTR will be unattended from 21/12/2018 until 08/01/2019. During this time no submissions or updates will be processed. Please ensure all trials are submitted/updated as soon as possible if you wish for them to be reviewed prior to the unattended period.

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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

Primary outcome [1] 290619 0
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
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).

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
Both males and females
Can healthy volunteers participate?
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
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Impax Pharmaceuticals, A Division of Impax Laboratories, Inc.
31047 Genstar Road,
Hayward, CA 94544
United States of America
Secondary sponsor category [1] 286780 0
Name [1] 286780 0
Address [1] 286780 0
Country [1] 286780 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 289982 0
Approval date [1] 289982 0
Ethics approval number [1] 289982 0

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

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
Phone 43366 0
+61 08 8222-4638
Fax 43366 0
Email 43366 0
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
Phone 43367 0
1800 150 433
Fax 43367 0
Email 43367 0
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
Phone 43368 0
+61 08 8222-4638
Fax 43368 0
Email 43368 0

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