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Trial registered on ANZCTR
Registration number
ACTRN12619000189123
Ethics application status
Approved
Date submitted
29/01/2019
Date registered
11/02/2019
Date last updated
7/10/2021
Date data sharing statement initially provided
11/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot 2-way crossover pharmacokinetic (PK) study (Part A) followed
by a pivotal 2-way crossover PK study to assess bioequivalence
(Part B) between a test and reference intravenous formulations of
150 mg Fosaprepitant
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Scientific title
A pilot 2-way crossover pharmacokinetic (PK) study (Part A) followed
by a pivotal 2-way crossover PK study to assess bioequivalence
(Part B) between a test and reference intravenous formulations of
150 mg Fosaprepitant in healthy volunteers
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Secondary ID [1]
297005
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None
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Universal Trial Number (UTN)
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Trial acronym
CP-NVK016-0001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
prevention of nausea and vomiting caused by Chemotherapy
310974
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Condition category
Condition code
Oral and Gastrointestinal
309637
309637
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
150mg intravenous Fosaprepitant (NVK016 manufactured by Nevakar Inc) prepared in 150ml solution is administered as a single intravenous dose.
Part A is the pilot study and will consist of twelve healthy male and female participants (participants that do not complete Part A may be replaced), gender balanced to the extent possible, each receiving a single 150 mg intravenous dose of a test or reference fosaprepitant in a randomized 2-way crossover study with a 7-day washout interval between the two study periods followed by single intravenous dose of the alternate.
Part B is planned to consist of up to forty-four healthy male and female participants, gender balanced to the extent possible, each receiving a single 150 mg intravenous dose of a test and reference Fosaprepitant in a randomized 2-way crossover study with a 7-day washout interval between the two study periods.
The participants in Part A and Part B will not be the same, however will be the same in period 1 and 2 in each Part.
The PK data from the Part A pilot study, as well as clinical safety, will be reviewed to inform a
decision on the number of completed participants required to assess bioequivalence for the Part B study.
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Intervention code [1]
313281
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Prevention
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Comparator / control treatment
EMEND® (fosaprepitant) injection, 150 mg manufactured by Merck. Single intravenous dose in each of two study periods administered as infusion. The dose is 150mg fosaprepitant in 150ml solution.
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Control group
Active
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Outcomes
Primary outcome [1]
318597
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Part A: To assess inter- and intra-subject variability of the pharmacokinetics of Aprepitant
following intravenous administration of test and reference fosaprepitant. The PK parameters are: tmax, Cmax, AUClast, AUCinf, kel and t1/2.
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Assessment method [1]
318597
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Timepoint [1]
318597
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Pre-dose (within 1 hour prior to the start of the infusion) and at 15 minutes (mid-infusion) and at 30 minutes (end of infusion). Further blood samples for PK will be collected at 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 12 hr post end of infusion, and then at 24 hr, 36 hr, 48 hr, 72, hr and 96 hr post end of infusion.
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Primary outcome [2]
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Part B: To determine bioequivalence of test and reference intravenous formulation of 150 mg fosaprepitant.
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Assessment method [2]
318598
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Timepoint [2]
318598
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Bioequivalence between the test and reference treatments in Part B will be based on the PK parameters, AUClast, AUCinf, and Cmax.
Pre-dose (within 1 hour prior to the start of the infusion) and at 15 minutes (mid-infusion) and at 30 minutes (end of infusion). Further blood samples for PK will be collected at 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 12 hr post end of infusion, and then at 24 hr, 36 hr, 48 hr, 72, hr and 96 hr post end of infusion..
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Secondary outcome [1]
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Part A and Part B: To assess the safety and tolerability of test and reference intravenous formulation of 150 mg fosaprepitant through physical examination, vital signs, 12 lead ECG, Hematology, Serum Chemistry and Urinalysis, review of conmeds and AEs including infusion site reactions.
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Assessment method [1]
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Timepoint [1]
365485
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Safety and tolerability will be monitored as composite outcome throughout the study period i.e from Day 1 to Day 7 in each period.
Physical examination - Day 1, 2 and 7
Vital signs - Day 1, 2, 3, 4, 5, 7
12 lead ECG - Day 1, 2 and 7
Hematology, Serum Chemistry and Urinalysis - Day 1, 2 and 7
Review of conmeds and AEs including infusion site reactions: Day 1, 2, 3 4, 5 and 7
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Eligibility
Key inclusion criteria
Male or female aged 18 to 55 years, healthy as determined by pre-study medical history, physical examination (PE), vital signs, complete neurological examination and 12-lead electrocardiogram (ECG) confirming normal sinus rhythm;
laboratory screening tests should be within normal limits or any abnormalities should be not clinically significant. Negative screen for alcohol and drugs of abuse at screening and admission . Non-smokers or ex-smokers (must have ceased smoking >3 months prior screening visit);
Female participants:
Must be of non-child-bearing potential OR must not be pregnant, breast feeding, or planning to become pregnant
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary,immunological, dermatological, endocrine, connective tissue diseases or disorders. Have a history of severe drug allergy, or hypersensitivity or severe food allergy
Consume more than 21 units of alcohol a week 6. Have used any investigational drug or participated in any clinical trial within 30 days prior to screening. Have donated or received any blood or blood products within the 3 months prior to screening;
Are unlikely to co-operate with the requirements, including duration of admission to the
study and expected follow up visit. Are unwilling or unable to give written informed consent. Have blood coagulation test results (prothrombin time (PT), activated partial thromboplastin time (APTT)) that are outside of the normal range.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Safety concerns
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Date of first participant enrolment
Anticipated
25/02/2019
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Actual
16/04/2019
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Date of last participant enrolment
Anticipated
29/07/2019
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Actual
16/07/2019
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Date of last data collection
Anticipated
12/08/2019
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Actual
29/07/2019
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Sample size
Target
56
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12841
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
25313
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
301576
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Commercial sector/Industry
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Name [1]
301576
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Nevakar Inc
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Address [1]
301576
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NJ Center of Excellence
1019 Route 202/206, Bldg. K
Bridgewater, NJ 08807, United States
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Country [1]
301576
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Nevakar Inc
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Address
NJ Center of Excellence
1019 Route 202/206, Bldg. K
Bridgewater, NJ 08807, United States
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Country
United States of America
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Secondary sponsor category [1]
301273
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None
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Name [1]
301273
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Address [1]
301273
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Country [1]
301273
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302305
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Bellberry Human Research Ethics Committee
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Ethics committee address [1]
302305
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129 Glen Osmond Road, Eastwood, South Australia 5063
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Ethics committee country [1]
302305
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Australia
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Date submitted for ethics approval [1]
302305
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19/12/2018
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Approval date [1]
302305
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24/01/2019
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Ethics approval number [1]
302305
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Summary
Brief summary
Nevakar Inc. is developing NVK016 which is a ready to use formulation for IV administration that contains 1 mg of fosaprepitant free acid per 1 mL of solution.
This study will be conducted in upto 56 normal healthy subjects who meet all of the inclusion criteria and none of the exclusion criteria.
This study aims to demonstrate bioequivalence of a test formulation of NVK016 (150 mg
Fosaprepitant, Nevakar, Inc.) with EMEND® (fosaprepitant) for injection, 150 mg (Merck) as the reference formulation.
This is a two part open-label pharmacokinetic (PK) study designed to assess bioequivalence between a test (T) and reference (R) formulation of 150 mg Fosaprepitant.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ben Snyder
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Address
89762
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Nucleus Network Pty Ltd
Level 5 Burnet Building AMREP Precinct
89 Commercial Rd
Melbourne Vic 3004
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Country
89762
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Australia
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Phone
89762
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+61 3 8593 9838
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Fax
89762
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Email
89762
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[email protected]
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Contact person for public queries
Name
89763
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Dr Ben Snyder
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Address
89763
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Nucleus Network Pty Ltd
Level 5 Burnet Building AMREP Precinct
89 Commercial Rd
Melbourne Vic 3004
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Country
89763
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Australia
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Phone
89763
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+61 3 8593 9838
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Fax
89763
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Email
89763
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[email protected]
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Contact person for scientific queries
Name
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Dr Eric Lang
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Address
89764
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NJ Center of Excellence
1019 Route 202/206, Bldg. K
Bridgewater, NJ 08807, United States
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Country
89764
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United States of America
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Phone
89764
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+1 908-367-7416
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Fax
89764
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Email
89764
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
It’s a healthy volunteer study and the individual participant results are not useful to the participants or to others outside of the sponsor
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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.
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