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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
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
Secondary ID [1] 297005 0
None
Universal Trial Number (UTN)
Trial acronym
CP-NVK016-0001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention of nausea and vomiting caused by Chemotherapy 310974 0
Condition category
Condition code
Oral and Gastrointestinal 309637 309637 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313281 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 318597 0
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.
Timepoint [1] 318597 0
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.
Primary outcome [2] 318598 0
Part B: To determine bioequivalence of test and reference intravenous formulation of 150 mg fosaprepitant.
Timepoint [2] 318598 0
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..
Secondary outcome [1] 365485 0
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.
Timepoint [1] 365485 0
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

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
25/02/2019
Actual
16/04/2019
Date of last participant enrolment
Anticipated
29/07/2019
Actual
16/07/2019
Date of last data collection
Anticipated
12/08/2019
Actual
29/07/2019
Sample size
Target
56
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12841 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 25313 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 301576 0
Commercial sector/Industry
Name [1] 301576 0
Nevakar Inc
Country [1] 301576 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nevakar Inc
Address
NJ Center of Excellence
1019 Route 202/206, Bldg. K
Bridgewater, NJ 08807, United States
Country
United States of America
Secondary sponsor category [1] 301273 0
None
Name [1] 301273 0
Address [1] 301273 0
Country [1] 301273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302305 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 302305 0
Ethics committee country [1] 302305 0
Australia
Date submitted for ethics approval [1] 302305 0
19/12/2018
Approval date [1] 302305 0
24/01/2019
Ethics approval number [1] 302305 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89762 0
Dr Ben Snyder
Address 89762 0
Nucleus Network Pty Ltd
Level 5 Burnet Building AMREP Precinct
89 Commercial Rd
Melbourne Vic 3004
Country 89762 0
Australia
Phone 89762 0
+61 3 8593 9838
Fax 89762 0
Email 89762 0
b.snyder@nucleusnetwork.com.au
Contact person for public queries
Name 89763 0
Ben Snyder
Address 89763 0
Nucleus Network Pty Ltd
Level 5 Burnet Building AMREP Precinct
89 Commercial Rd
Melbourne Vic 3004
Country 89763 0
Australia
Phone 89763 0
+61 3 8593 9838
Fax 89763 0
Email 89763 0
b.snyder@nucleusnetwork.com.au
Contact person for scientific queries
Name 89764 0
Eric Lang
Address 89764 0
NJ Center of Excellence
1019 Route 202/206, Bldg. K
Bridgewater, NJ 08807, United States
Country 89764 0
United States of America
Phone 89764 0
+1 908-367-7416
Fax 89764 0
Email 89764 0
elang@nevakar.com

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


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.