THE EFFECT OF ABIRATERONE ON THE METABOLISM OF OXYCODONE (ENABLE study)
EU CTIS ID: 2023-505705-17-00
What this study is testing
To investigate the effect of abiraterone on the pharmacokinetics (PK) of oxycodone following a single dose of 15 mg normal-release oxycodone in men with prostate cancer.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Diagnosed prostate cancer; - Males aged 18 years; - Treated with abiraterone 1000 mg once daily for at least 10 days (arm 1). - Not treated with abiraterone 1000 mg once daily for at least 10 days (arm 2).
You likely can't join if
- - A body mass index (BMI) outside the range of 18 – 30 kg/m2; - If hypersensitive to oxycodone; patients suffering from diarrhoea and/or opioid withdrawal; - 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 ; - 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; - Subjects with significant respiratory depression, acute or severe bronchial asthma or hypercarbia; - If subjects started first cycle of chemotherapy during the 2 weeks before the screening visit - Major surgery within 1 month prior to screening or planned surgery; - Severe Chronic obstructive pulmonary disease, pulmonary heart disease; - Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine); - 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.