Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517646-34-00

Enrollment

Registered

2024-11-15

Start date

2023-02-01

Completion date

2025-07-15

Last updated

2024-11-15

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

Conditions

Prostate cancer

Brief summary

To determine the change in edoxaban and M4 exposure (AUC0-24hr) with or without enzalutamide - To determine the change in morphine and morphine-6- glucuronide exposure (AUC0-12hr) with or without enzalutamide

Detailed description

If a patient also has a treatment indication with opioids for pain: To evaluate the pain control (with the Numeric Rating Scale) in patients treated with and without enzalutamide and morphineTo evaluate the safety of the combination of enzalutamide with edoxaban and/or morphine monitored with CTC-AE v 5.0 criteria. - To evaluate the effect of edoxaban and/or morphine on enzalutamide exposure

Interventions

DRUGENZALUTAMIDE

DRUGMORPHINE

DRUGEDOXABAN

Eligibility

Sex/Gender

Male

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To determine the change in edoxaban and M4 exposure (AUC0-24hr) with or without enzalutamide - To determine the change in morphine and morphine-6- glucuronide exposure (AUC0-12hr) with or without enzalutamide	—

Secondary

Measure	Time frame
If a patient also has a treatment indication with opioids for pain: To evaluate the pain control (with the Numeric Rating Scale) in patients treated with and without enzalutamide and morphineTo evaluate the safety of the combination of enzalutamide with edoxaban and/or morphine monitored with CTC-AE v 5.0 criteria. - To evaluate the effect of edoxaban and/or morphine on enzalutamide exposure	—

Countries

Netherlands

Outcome results

None listed

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