Pain in prostate cancer
Conditions
Interventions
Subjects will receive a single oral dose of normal-release oxycodone 15 mg.
Sponsors
Deventer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Males aged >= 18 years; - Diagnosed prostate cancer; - Treated with enzalutamide 160 mg once daily for 40 days (arm 1)
Exclusion criteria
Exclusion criteria: - a body mass index (BMI) outside the range of 18 to 30 kg/m2; - known metastases in the liver that would affect drug metabolism; - Child-Pugh classification B or C that would affect drug metabolism; - known CYP3A4 or CYP2D6 polymorphisms that would affect drug metabolism (patients with a known CYP3A4 or CYP2D6 polymorphism afterwards will be replaced); - known moderate-severe renal dysfunction (GFR =5 successive days of treatment interruption of enzalutamide within 40 days prior to the study day (arm 1); - treatment with enzalutamide within 40 days prior to the study day (arm 2); - use of oxycodone normal-release within 24 hour prior to oxycodone intake or use of oxycodone extended-release within 2 days prior to oxycodone intake; - use of other medication that would affect oxycodone metabolism, see section 5.2 and appendix B of the study protocol; - use of other medication that would affect enzalutamide metabolism, see section 5.2 and appendix B of the study protocol (arm 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in pharmacokinetics of oxycodone in the presence and absence of enzalutamide, expressed in Cmax and AUC0-t. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in pharmacokinetics in the presence and absence of enzalutamide, expressed in: 1. Maximum plasmaconcentration (Cmax) of noroxycodone, oxymorphone and noroxymorphone; 2. Area under the plasma concentration versus time curve from time zero to the time (t) corresponding to the last quantifiable concentration (AUC0-t) of noroxycodone, oxymorphone and noroxymorphone; 3. Area under the concentration-time curve from time zero to infinity with extrapolation of the terminal phase (AUC0-*) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone; 4. Terminal half-life (t1/2) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone. | — |
Countries
Netherlands
Outcome results
None listed