De influence of lipid digestion on the drug abiraterone acetate in the small intestine after oral administration to human volunteers

The influence of gastrointestinal lipid digestion on the intraluminal behavior of abiraterone acetate in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003460-50-BE

Enrollment

Registered

2019-09-17

Start date

2019-10-30

Completion date

Unknown

Last updated

2024-06-10

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

Conditions

Healthy human volunteers

Interventions

Trade Name: Zytiga 500 mg 56 tabletten Pharmaceutical Form: Tablet Trade Name: Xenical 120 mg 84 harde capsullen Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy male volunteers Age between 18 and 40 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women Acute/chronic gastrointestinal/liver/cardiac disease Use of medication (CYP3A4 inductor) Frequent exposure to X-rays during the past year HIV/HBV/HCV infection (Possible) pregnancy of partner Allergies for excipients

Design outcomes

Primary

Measure	Time frame
Main Objective: The study aims to investigate the influence of lipid digestion on abiraterone acetate along the intestinal tract in healthy human volunteers. The study will be conducted in fasted and fed state, with and without inhibition of lipid digestion.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery and Disposition

KU Leuven

marlies.braeckmans@kuleuven.be003216330301

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026