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
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
Nevakar Inc
56 participants
Apr 16, 2019
Interventional
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria4
- 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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Interventions
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.
Locations(1)
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ACTRN12619000189123