RecruitingPhase 4NCT07001709

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

The Effect of Abiraterone on the Metabolism of Oxycodone


Sponsor

Deventer Ziekenhuis

Enrollment

29 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether abiraterone — a prostate cancer drug — affects how the body breaks down oxycodone, a common pain medication. Understanding this interaction could help doctors prescribe pain medications more safely to men on abiraterone. **You may be eligible if...** - You are a male 18 or older with prostate cancer - You are either currently taking abiraterone (1000 mg daily for at least 10 days) — or you are not taking it (as a comparison group) - Your BMI is between 18 and 30 kg/m² - You have adequate kidney and liver function **You may NOT be eligible if...** - You have used oxycodone recently (within 48 hours for short-acting, 96 hours for long-acting) - You have used other opioids in the past 14 days - You are taking other medications that interact with oxycodone - You have significant liver, kidney, or respiratory problems - You have a known allergy to oxycodone or a CYP enzyme variation that affects drug metabolism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxycodone oral capsule 15 mg

Single dose of 15 mg oxycodone direct release (both arm 1 and arm 2)

DRUGAbiraterone Acetate Tablets 500 mg

Abiraterone group: 1000 mg abiraterone acetate (at steady state)


Locations(1)

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

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NCT07001709


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