Prostate Cancer MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Cla
Conditions
Interventions
Trade Name: Oxycodone
Pharmaceutical Form: Capsule, hard
Sponsors
Deventer Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Males aged = 18 years; - Diagnosed prostate cancer; - Treated with enzalutamide 160 mg once daily for 40 days (arm 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
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 <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 48 hours prior to oxycodone intake or use of oxycodone extended-release within 4 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 |
|---|---|
| Main Objective: To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer, expressed in Cmax and AUC0-t.;Secondary Objective: 1. To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer, expressed in AUC0-8 and t1/2. 2. To investigate the effect of enzalutamide on the pharmacokinetics (PK) of oxycodone its metabolites noroxycodone, oxymorphone and noroxymorphone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer, expressed in Cmax, AUC0-t, AUC0-8 and t1/2. ;Primary end point(s): Maximum serum concentration (Cmax) and 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;Timepoint(s) of evaluation of this end point: Plasma sampling at t=0.5, 1, 1.5, 2, 3, 5, 8 hours after intake of oxycodone. Evaluation of the endpoint will be done after completion of all plasma samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 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. ;Timepoint(s) of evaluation of this end point: Plasma sampling at t=0.5, 1, 1.5, 2, 3, 5, 8 hours after intake of oxycodone. Evaluation of the endpoint will be done after completion of all plasma samples. | — |
Countries
Netherlands
Contacts
Public ContactSuzan Detert Oude Weme
Deventer Hospital
Outcome results
None listed