THE EFFECT OF ABIRATERONE ON THE METABOLISM OF OXYCODONE (ENABLE study)

Phase 1

• Conditions: Males aged ? 18 years with prostate cancer treated with abiraterone (arm 1) or not treated with abiraterone (arm 2). Patients with abiraterone treatment will take abiraterone 1000 mg per day.; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Phenomena and Processes [G] - Metabolism [G03]

• Registration Number: CTIS2023-505705-17-00
• Lead Sponsor: Deventer Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

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).

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To determine the effect of abiraterone on the PK oxycodone’s metabolites noroxycodone, oxymorphone and noroxymorphone following a single 15 mg oral dose of normal-release oxycodone in men with prostate cancer;Primary end point(s): Difference in the pharmacokinetics of oxycodone in patients with prostate cancer treated with abiraterone (arm 1) versus not treated with abiraterone, expressed in Cmax, AUC0-8h and t1/2.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):The difference in pharmacokinetics of the metabolites of oxycodone in patients treated with abiraterone versus not treated with abiraterone, expressed in Cmax and AUC0-0-8h.