Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorDeventer Ziekenhuis
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Oxycodone oral capsule 15 mg
DrugSingle dose of 15 mg oxycodone direct release (both arm 1 and arm 2)
Abiraterone Acetate Tablets 500 mg
DrugAbiraterone group: 1000 mg abiraterone acetate (at steady state)
Treatment groups
29 Participants
are divided into 2 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Abiraterone groupOther 2 interventions
Trial outcomes
Primary outcomes
1
Cmax Oxycodone
Maximum measured concentration of oxycodone
Time frame
Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)2
T1/2 oxycodone
Measured half-life of oxycodone
Time frame
t= 0.5, 1, 1.5, 2, 3, 5, 8 hours3
AUC0-8h oxycodone
Area under the curve of oxycodone from 0 to 8 hours after ingestion of oxycodone.
Time frame
From 0 to 8 hours after ingestion of oxycodoneSecondary outcomes
1
Cmax noroxycodone
Maximum measured concentration of noroxycodone
Time frame
Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)2
AUC0-8h noroxycodone
Area under the curve of noroxycodone from 0 to 8 hours after ingestion of oxycodone.
Time frame
From 0 to 8 hours after ingestion of oxycodone3
Cmax oxymorphone
Maximum measured concentration of oxymorphone
Time frame
Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)4
AUC0-8h oxymorphone
Area under the curve of oxymorphone from 0 to 8 hours after ingestion of oxycodone.
Time frame
From 0 to 8 hours after ingestion of oxycodoneSponsors and contacts
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Source ClinicalTrials.gov