The Effect of Abiraterone on the Metabolism of Oxycodone (Enable Study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Deventer Ziekenhuis

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Male Urogenital Diseases [C12], Phenomena and Processes [G] - Metabolism [G03]

Trial duration

23 Feb 2024 → ongoing

Decision date (initial)

2023-08-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

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 objectives 1

1. 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

Conditions and MedDRA coding

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.

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. - 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 1

1. - 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Deventer Ziekenhuis

Sponsor organisation

Deventer Ziekenhuis

Address

Nico Bolkesteinlaan 75

City

Deventer

Postcode

7416 SE

Country

Netherlands

Scientific contact point

Organisation

Deventer Ziekenhuis

Contact name

Prof. Dr. Frank Jansman

Public contact point

Organisation

Deventer Ziekenhuis

Contact name

Prof. Dr. Frank Jansman

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications