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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505705-17-00

Enrollment

Registered

2023-08-30

Start date

2024-02-23

Completion date

Unknown

Last updated

2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Brief summary

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.

Detailed description

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.

Interventions

DRUGOxycodon HCl Aurobindo 5 mg

DRUGcapsules hard

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026