Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)

Summary

Prostate cancer often leads to bone metastases, which require adequate pain management with opioids such as oxycodone. This study investigates whether abiraterone - a drug used in the treatment of prostate cancer - affects the pharmacokinetics of oxycodone in order to improve pain management.

Eligibility

Inclusion Criteria:

* Diagnosed prostate cancer;
* Males aged 18 years or older;
* Treated with abiraterone 1000 mg once daily for at least 10 days (abiraterone arm).
* Not treated with abiraterone 1000 mg once daily for at least 10 days (control arm).

Exclusion Criteria:

* Use of oxycodone short acting \<48 hours, or long acting \<96 hours prior to the study day;
* Use of other opioids in the 14 days prior to the study day (see also appendix A);
* Use of other medication that has pharmacokinetic or pharmacodynamics interactions with oxycodone (see also appendix A);
* Arm 1: dose reduction or successive days of treatment interruption within 10 days prior to the study day (arm 1);
* Arm 2: treatment with abiraterone within 10 days prior to the study day;
* A body mass index (BMI) outside the range of 18 - 30 kg/m2;
* If hypersensitive to oxycodone;
* patients suffering from diarrhea
* If any type of abnormality; active or symptomatic viral hepatitis or chronic liver disease (e.g. classification with Child-Pugh B, Child-Pugh C);
* Known metastases in the liver that would affect drug metabolism;
* Patients with a CYP3A4 or CYP2D6 polymorphism;
* Moderate-severe renal dysfunction (GFR \<60 ml/min/1.73m2) that affects drug metabolism ;
* Subjects with significant respiratory depression resulting in the need of oxygen therapy or objective hypoventilation (respiratory rate \<12/min);
* Hypercapnia (venous pCO2 outside the range of 5.5 - 6.7; pH outside the range 7.30 - 7.40);
* Subjects with, a history of bronchial asthma, chronic obstructive pulmonary disease or pulmonary heart disease;
* Subjects who started their first cycle of chemotherapy during the 2 weeks before the study day;
* Major surgery within 1 month prior to screening or planned surgery;
* A history of drug abuse
* Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine) and/or suffering from opioid withdrawal
* Patients with evidence of clinically significant gastrointestinal disease;
* Patients who are contraindicated for blood sampling;
* Unable to swallow solid, oral dosage forms whole with water;
* Participation in a clinical trial study at the time of enrolment or within 30 days or 5 half-lives of enrolment, whichever is longer;
* Previous gastric bypass or gastric band surgery.

Conditions3

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