Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000740392
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
22/05/2017
Date last updated
17/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 600 mg imatinib tablet against the innovator imatinib tablet conducted under fed conditions in healthy male volunteers
Scientific title
A single dose, randomized, blinded, bioequivalence study of a test formulation of imatinib tablet in a 3 way crossover comparison against the innovator imatinib tablets conducted under fed conditions in healthy male volunteers
Secondary ID [1] 291879 0
None
Universal Trial Number (UTN)
U1111-1193-6757
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukaemia
 303174 0
Blood Disorders 303359 0
Cancer 303360 0
Condition category
Condition code
Cancer 302614 302614 0 0
Leukaemia - Chronic leukaemia
Cancer 302615 302615 0 0
Stomach
Blood 302786 302786 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of imatinib (1 x 600 mg) on one occasion, the innovator formulation of imatinib (formulation 1) (1 x 400 mg and 2 x 100 mg) on one occasion and the innovator formulation of imatinib (formulation 2) (1 x 400 mg and 2 x 100 mg) on one occasion with each dose seperated by a two week washout period. The intervention for this trial is the test formulation of imatinib.

No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with the dose).

Participants are required not to eat for 10 hours prior to receiving breakfast. Subjects will be provided with a standardised high fat breakfast which they must start eating 30 minutes prior to dosing. Subjects are required to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance.

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.

Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 297998 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation of imatinib (1 x 600 mg) on one occasion and the innovator formulation of imatinib (formulation 1) (1 x 400 mg and 2 x 100 mg) on one occasion and the innovator formulation of imatinib (formulation 2) (1 x 400 mg and 2 x 100 mg) on one occasion with each dose seperated by a two week washout period. The difference between the two innovator formulations is the country of origin of each one. The comparator/control for this trial is the innovator formulations of imatinib.
Control group
Active

Outcomes
Primary outcome [1] 302111 0
To compare the bioavailability of imatinib (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for imatinib using one fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 302111 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56 and 72 hours post dosing
Secondary outcome [1] 334829 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] 334829 0
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 32, 48, 56 and 72 hours post dosing

Eligibility
Key inclusion criteria
Healthy male
Aged between 18 and 55
Non-smoker
BMI between 18 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to imatinib or any other similar class of medicines, or the excipients of imatinib
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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 in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, 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, B and C. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.

Each participant will be identified by 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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced three-way crossover design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 8901 0
New Zealand
State/province [1] 8901 0
Otago

Funding & Sponsors
Funding source category [1] 296380 0
Commercial sector/Industry
Name [1] 296380 0
Juno Pharmaceuticals Pty Ltd
Country [1] 296380 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 295326 0
None
Name [1] 295326 0
Address [1] 295326 0
Country [1] 295326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297618 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 297618 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 297618 0
New Zealand
Date submitted for ethics approval [1] 297618 0
16/06/2017
Approval date [1] 297618 0
11/07/2017
Ethics approval number [1] 297618 0
17/CEN/109

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 1 x 600 mg imatinib tablet against the reference formulation 1 (innovator brand of 1 x 400 mg and 2 x 100 mg imatinib tablet) and the reference formulation 2 (innovator brand of 1 x 400 mg and 2 x 100 mg imatinib tablet) following oral administration of a single dose of 600 mg in healthy male subjects under fed conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74606 0
Dr Noelyn Hung
Address 74606 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 74606 0
New Zealand
Phone 74606 0
+6434779669
Fax 74606 0
+6434779605
Email 74606 0
[email protected]
Contact person for public queries
Name 74607 0
Mrs Linda Folland
Address 74607 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 74607 0
New Zealand
Phone 74607 0
+6434779669
Fax 74607 0
+6434779605
Email 74607 0
[email protected]
Contact person for scientific queries
Name 74608 0
Dr Tak Hung
Address 74608 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 74608 0
New Zealand
Phone 74608 0
+6434779669
Fax 74608 0
+6434779605
Email 74608 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.