Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001135202
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
11/07/2018
Date last updated
26/10/2021
Date data sharing statement initially provided
26/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative bioavailability assessment between 4 x 60 mg R107 tablets administered orally and 0.5mg/kg ketamine IV infusion over 40 minutes in healthy male and female participants under fasting conditions.
Scientific title
A single dose, randomised, 2-period, 2-sequence, crossover, comparative bioavailability study between 4 x 60 mg R107 tablets administered orally and 0.5mg/kg ketamine IV infusion over 40 minutes in healthy male and female participants under fasting conditions.
Secondary ID [1] 295511 0
None
Universal Trial Number (UTN)
U1111-1211-4697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 308776 0
Anxiety 308777 0
Condition category
Condition code
Mental Health 307713 307713 0 0
Depression
Mental Health 307714 307714 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 4 x 60 mg R107 tablets on one occasion and the innovator formulation 0.5mg/kg ketamine IV infusion over 40 minutes on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test R107 formulation.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the oral dose).
Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 24 hours after dosing.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing.

Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing.

The test formulation dose will be taken orally with 240 ml of water at ambient temperature. The R107 tablets must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed. The IV infusion will be administered over 40 minutes.
Intervention code [1] 301828 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation (4 x 60 mg) on one occasion and the innovator formulation ( 0.5mg/kg ) on one occasion with each dose separated by a one week washout period. The comparator/control for this trial is the innovator IV solution formulation.
Control group
Active

Outcomes
Primary outcome [1] 306700 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC). All plasma samples will be assayed for ketamine and norketamine using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 306700 0
IV infusion: Sampling immediately prior to dosing and at 5, 10, 20, 40, 45, and 50 minutes, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 32 and 48 hours post dosing.

Oral: Sampling immediately prior to dosing and at 30 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 14, 17, 20, 24, 32 and 48 hours post dosing.
Secondary outcome [1] 349299 0
Time to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 349299 0
IV infusion: Sampling immediately prior to dosing and at 5, 10, 20, 40, 45, and 50 minutes, and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 32 and 48 hours post dosing.

Oral: Sampling immediately prior to dosing and at 30 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 12, 14, 17, 20, 24, 32 and 48 hours post dosing.

Eligibility
Key inclusion criteria
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 30
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
The absence of mental illness requiring medication or treatment by a physician.
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Concomitant drug therapy of any kind
Any history of mental illness requiring medication or treatment by a physician.
Receiving treatment with monoamine oxidase inhibitors, vasoconstriction agents, thyroxine or benzodiazepines.
History of significant drug abuse or dependency including ketamine or its excipients within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
Sensitive to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk

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)
All formulations will be labelled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and the Section Head - Trails and Regulatory Affairs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be given a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study. Sequence generation will be by using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 10638 0
New Zealand
State/province [1] 10638 0
Otago

Funding & Sponsors
Funding source category [1] 300093 0
Commercial sector/Industry
Name [1] 300093 0
Douglas Pharmaceuticals Limited
Country [1] 300093 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 299495 0
None
Name [1] 299495 0
Address [1] 299495 0
Country [1] 299495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300940 0
Southern Health and Disiability Ethics Committee
Ethics committee address [1] 300940 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 300940 0
New Zealand
Date submitted for ethics approval [1] 300940 0
29/03/2018
Approval date [1] 300940 0
27/04/2018
Ethics approval number [1] 300940 0
18/STH/80

Summary
Brief summary
The objective of this study is to evaluate the comparative bioavailability of the test formulation relative to that of a reference formulation, following oral administration of a single dose of 4 x 60 mg R107 tablets and 0.5 mg/kg ketamine IV infusion over 40 minutes to healthy male and female subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85354 0
Dr Noelyn Hung
Address 85354 0
Zenith Technology Corp Ltd
156 Frederick Street, (PO Box 1777)
Dunedin 9016
Country 85354 0
New Zealand
Phone 85354 0
+6434779669
Fax 85354 0
+6434779605
Email 85354 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 85355 0
Mrs Linda Folland
Address 85355 0
Zenith Technology Corp Ltd
156 Frederick Street, (PO Box 1777)
Dunedin 9016
Country 85355 0
New Zealand
Phone 85355 0
+6434779669
Fax 85355 0
+6434779605
Email 85355 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 85356 0
Dr Tak Hung
Address 85356 0
Zenith Technology Corp Ltd
156 Frederick Street, (PO Box 1777)
Dunedin 9016
Country 85356 0
New Zealand
Phone 85356 0
+6434779669
Fax 85356 0
+6434779605
Email 85356 0
tak.hung@zenithtechnology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.