Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001338156
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
30/09/2019
Date last updated
2/07/2021
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule against the innovator 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule conducted under fasting conditions in healthy male volunteers.
Scientific title
A single dose, randomized, blinded, pharmacokinetic study of a test formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule in a 2 way crossover comparison against the innovator 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule conducted under fasting conditions in healthy male volunteers.
Secondary ID [1] 299310 0
None
Universal Trial Number (UTN)
U1111-1236-7250
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. 314444 0
Condition category
Condition code
Cancer 312782 312782 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 4 mg 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule on one occasion and the innovator formulation 4 mg 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test capsule formulation

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

Participants are required not to eat for 10 hours before dosing and to fast for approximately 4 hours after each dose.

Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety.

Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 24 hours after dosing.

Participants will be monitored for adverse events throughout the study.

Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and urine dipstick drugs of abuse testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing.

Screening and study exit laboratory tests will be completed to assess the health of the 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 that the medication has been taken as directed.
Intervention code [1] 315579 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione (1 x 4 mg) on one occasion and the innovator formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione (1 x 4 mg) on one occasion with each dose separated by a one week washout period. The comparator/control for this trial is the innovator capsule formulation
Control group
Active

Outcomes
Primary outcome [1] 321402 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 321402 0
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20, 24, 32 and 48 hours post dosing.
Secondary outcome [1] 374883 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] 374883 0
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20, 24, 32 and 48 hours post dosing.

Eligibility
Key inclusion criteria
Healthy males
Aged between 18 and 55 years
Non-smoker
BMI greater than or equal to 18.5 and less than 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Drug free as determined by urine drug testing
Able to comply with the study restrictions
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females
Clinically significant medical conditions
History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
History of alcohol or drug abuse or dependency
Participation in a drug study within 30 days of the start of the study
Sensitivities to the study drug or excipients
Individuals 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 labeled as Formulation A and B. The identification of each treatment will only be known to the Managing Director and Section Head - Trials and Regulatory Affairs or their delegate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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 study number (randomisation number) after acceptance into the study. Randomization will be performed using a randomisation table created by computer software (i.e. computerized sequence generation).
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
Completed
Date of first participant enrolment
Anticipated
12/10/2019
Actual
3/10/2019
Date of last participant enrolment
Anticipated
Actual
9/10/2019
Date of last data collection
Anticipated
Actual
21/10/2019
Sample size
Target
24
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 21863 0
New Zealand
State/province [1] 21863 0
Otago

Funding & Sponsors
Funding source category [1] 303830 0
Commercial sector/Industry
Name [1] 303830 0
Juno Pharmaceuticals Pty Ltd
Country [1] 303830 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
PO Box 1777
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 303957 0
None
Name [1] 303957 0
Address [1] 303957 0
Country [1] 303957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304345 0
Northern A Health & Disability Ethics Committee
Ethics committee address [1] 304345 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 304345 0
New Zealand
Date submitted for ethics approval [1] 304345 0
02/08/2019
Approval date [1] 304345 0
11/09/2019
Ethics approval number [1] 304345 0
19/NTA/110

Summary
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione relative to that of the reference formulation (innovator brand 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione capsule) following oral administration of a single dose of 4 mg 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione in healthy male subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96622 0
Dr Noelyn Hung
Address 96622 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 96622 0
New Zealand
Phone 96622 0
+64 3 477 9669
Fax 96622 0
+6434779605
Email 96622 0
[email protected]
Contact person for public queries
Name 96623 0
Linda Folland
Address 96623 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 96623 0
New Zealand
Phone 96623 0
+64 3 477 9669
Fax 96623 0
+6434779605
Email 96623 0
[email protected]
Contact person for scientific queries
Name 96624 0
Tak Hung
Address 96624 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 96624 0
New Zealand
Phone 96624 0
+64 3 477 9669
Fax 96624 0
+6434779605
Email 96624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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