Prostate cancer Pain
Conditions
Interventions
Oxycodone normal-release 15 mg single oral dose in the presence (experimental) and absence (control) of enzalutamide
Sponsors
Deventer Hospital
Eligibility
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: ? known metastases in the liver that would affect drug metabolism; ? Child-Pugh classification B or C that would affect drug metabolism; ? known moderate-severe renal dysfunction (GFR <60 ml/min/1.73m2) that would affect drug metabolism; ? gastrointestinal disorders that would potentially alter absorption; ? previous gastric bypass or gastric band surgery; ? known allergy, hypersensitivity or intolerance to normal-release oxycodone; ? a history of drug abuse or treatment for abuse; ? dose-reduction or =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; ? use of other medication that would affect enzalutamide metabolism, see section 5.2 and appendix B (arm 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in pharmacokinetics of oxycodone in the presence and absence of enzalutamide, expressed in maximum serum concentration (Cmax) of oxycodone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in pharmacokinetics of oxycodone in the presence and absence of enzalutamide, expressed in: 1. Maximum serum concentration (Cmax) of noroxycodone, oxymorphone and noroxymorphone; 2. Area under the serum concentration versus time curve from time zero to the time (t) corresponding to the last quantifiable concentration (AUC0-t) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone; 3. Area under the concentration-time curve from time zero to infinity with extrapolation of the terminal phase (AUC0-8) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone; 4. Terminal half-life (t1/2) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone. | — |
Contacts
Public ContactSuzan Detert Oude Weme
Deventer Ziekenhuis
Outcome results
None listed