Clinical trial NCT03889366: Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers
Official title: Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nuformix Technologies Limited
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will compare the relative bioavailability of both an oral capsule formulation and an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted state.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose
2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
3. History of any drug or alcohol abuse in the past 2 years
4. 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)
5. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
6. Current users of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
7. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
8. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
9. Confirmed positive drugs of abuse test result
10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
11. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, psychiatric or gastrointestinal (GI) disease as judged by the investigator
12. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
13. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
14. Donation or loss of greater than 400 mL of blood within the previous 3 months
15. 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.
16. Subjects who have taken any CYP3A4 inducers in the 30 days prior to IMP administration.
17. Failure to satisfy the investigator of fitness to participate for any other reason

Primary outcomes:
measure: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state
timeFrame: through 48 hours postdose
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) Following Single Dose Administration of NXP001 oral capsule, NXP001 oral suspension or Emend® in the fasted state
timeFrame: through 48 hours postdose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Limited
Study officials:
References: