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

Phase 4

Completed

• Conditions: Pain in prostate cancer; 10027656

• Registration Number: NL-OMON51266
• Lead Sponsor: Deventer Ziekenhuis

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-20
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

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

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 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in pharmacokinetics of oxycodone in the presence and absence of<br /><br>enzalutamide, expressed in Cmax and AUC0-t.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in pharmacokinetics in the presence and absence of enzalutamide,<br /><br>expressed in:<br /><br>1. Maximum plasmaconcentration (Cmax) of noroxycodone, oxymorphone and<br /><br>noroxymorphone;<br /><br>2. Area under the plasma concentration versus time curve from time zero to the<br /><br>time (t) corresponding to the last quantifiable concentration (AUC0-t) of<br /><br>noroxycodone, oxymorphone and noroxymorphone;<br /><br>3. Area under the concentration-time curve from time zero to infinity with<br /><br>extrapolation of the terminal phase (AUC0-*) of oxycodone and its metabolites<br /><br>noroxycodone, oxymorphone and noroxymorphone;<br /><br>4. Terminal half-life (t1/2) of oxycodone and its metabolites noroxycodone,<br /><br>oxymorphone and noroxymorphone.</p><br>