Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

Inclusion criteria

• Healthy males
• Body mass index (BMI) of 18.0 to 35.0 kg/m2 as assessed at screening
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must agree to use adhere to the contraception requirements of the study

Exclusion criteria

• Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Current users of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, psychiatric or gastrointestinal (GI) disease as judged by the investigator
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
• Subjects who have taken any CYP3A4 inducers in the 30 days prior to IMP administration.
• Failure to satisfy the investigator of fitness to participate for any other reason