NCT04295161

A Study Designed to Evaluate the Pharmacokinetic Profile of Abiraterone

A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Zentiva, k.s. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations

Detailed description

This was a single centre, 2 part, open-label study in healthy male subjects. Parts 1 and 2 were conducted in separate cohorts of subjects; subjects were not permitted to participate in both parts. Part 1 was a part-randomised, 4 period crossover study planned to include 24 healthy male subjects. Part 2 was a randomised 2-period crossover study in 12 healthy male subjects. The aim was to evaluate the pharmacokinetic profiles of abiraterone following administration of immediate release prototype formulations in healthy male subjects.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Abiraterone acetate immediate release formulations

Timeline

• Start date: 2019-06-25
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2020-03-04
• Last updated: 2020-03-04

Locations

1 site across 1 country: United Kingdom