The Effect Of Enzalutamide on Oxycodone Metabolism in Men with Prostate Cancer

• Conditions: Prostate cancerPain

• Registration Number: NL-OMON23562
• Lead Sponsor: Deventer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

? Males aged = 18 years;
? Diagnosed prostate cancer;
? Treated with enzalutamide 160 mg once daily for 40 days (arm 1)

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in pharmacokinetics of oxycodone in the presence and absence of enzalutamide, expressed in maximum serum concentration (Cmax) of oxycodone.

Secondary Outcome Measures

Name	Time	Method
Differences in pharmacokinetics of oxycodone in the presence and absence of enzalutamide, expressed in:<br>1. Maximum serum concentration (Cmax) of noroxycodone, oxymorphone and noroxymorphone;<br>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;<br>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;<br>4. Terminal half-life (t1/2) of oxycodone and its metabolites noroxycodone, oxymorphone and noroxymorphone.