Cancer Other
Conditions
Interventions
This study will investigate the PK, safety and tolerability of varying or increasing doses of LipAprep capsule formulation and optionally an immediate release aprepitant formulation. Each participant
volunteers may be given a higher dose or be dosed with a dose previously administered in the fed state.
Sponsors
Oxilio Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 18 – 55 at the time of signing informed consent 4. Must agree to adhere to the contraception requirements defined in the protocol 5. Healthy males, determined by no clinically significant findings on ECG, vital signs or urinalysis 6. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening 7. Weight =50 kg at screening
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 2. Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active. 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder 4. Subjects with a history of cholecystectomy or gall stones 5. History or presence of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 6. Subjects who do not have suitable veins for multiple venepunctures/cannulation 7. Evidence of current SARS-CoV-2 infection or recent infection within 4 weeks of first IMP administration or subjects who have ongoing symptoms attributed to COVID-19 8. Clinically significant abnormal clinical chemistry, haematology or urinalysis. Subjects with Gilbert’s Syndrome are allowed. 9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or HIV 1 and 2 antibody results 10. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer 11. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood 12. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration 13. History of any drug or alcohol abuse in the past 2 years 14. Regular alcohol consumption >21 units per week 15. A confirmed positive alcohol breath test at screening or admission 16. Current smokers and those who have smoked within the last 12 months 17. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months 18. Confirmed positive drugs of abuse test result, as detailed in the protocol 19. Consumption of a low-fat diet within 2 weeks of first dose 20. Male subjects with pregnant or lactating partners 21. Subjects who are, or are immediate family members of, a study site or sponsor employee 22. Failure to satisfy the investigator of fitness to participate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate the pharmacokinetic (PK) profiles of LipAprep (aprepitant lipidic capsule formulation) by measurement of PK parameters including but not limited to: Tlag, Tmax, Cmax, Cmax/D, C24, AUC(0-24), AUC(0-24)/D, AUC(0-last), AUC(0-last)/D, lambda-z, T1/2, and statistical assessment of dose proportionality, where applicable 2. To provide safety and tolerability information for LipAprep by assessing: incidence of adverse events (AEs), physical examinations and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate the PK profiles of aprepitant immediate release (IR) marketed reference formulation by measurement of PK parameters including but not limited to: Tlag, Tmax, Cmax, Cmax/D, C24, AUC(0-24), AUC(0-24)/D, AUC(0-last), AUC(0-last)/D, lambda-z and T1/2, where applicable 2. To assess the relative bioavailability of LipAprep compared to the IR marketed formulation by calculation of relative bioavailability (Frel) for Cmax, AUC(0-24) and AUC(0-last), including statistical assessment of relative bioavailability 3. Evaluate PK profiles of LipAprep at the same dose in the fed and fasted state by measurement of PK parameters including but not limited to: Tlag, Tmax, Cmax, Cmax/D, C24, AUC(0-24), AUC(0-24)/D, AUC(0-last), AUC(0-last)/D, lambda-z, T1/2, and statistical assessment of food effect, where applicable 4. To provide additional safety and tolerability information for aprepitant following oral administrations of an IR marketed formulation by assessment of the incidence of AEs, physical examinations and change from baseline for vital signs, ECGs, and laboratory safety tests | — |
Countries
England, United Kingdom
Contacts
Public ContactClinical Operations Department
Outcome results
None listed