A Study Designed to Evaluate the Pharmacokinetic Profile of Abiraterone

NCT04295161 | Completed Phase 1

• 1 other identifier: ABIRAL00005
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Abiraterone Cmax

  maximal concentration of abiraterone in human plasma

  24h

• Abiraterone AUC

  total exposure up to 24h of abiraterone in human plasma

  24h

Study Arms (6)

Reference

ACTIVE COMPARATOR

Drug: Abiraterone Acetate

Prototype 1

EXPERIMENTAL

Drug: Abiraterone Acetate

Prototype 2

EXPERIMENTAL

Drug: Abiraterone Acetate

Prototype 3

EXPERIMENTAL

Drug: Abiraterone Acetate

Prototype 4 fasted

EXPERIMENTAL

administered in fasted state

Drug: Abiraterone Acetate

Prototype 4 fed

EXPERIMENTAL

Administered in fed state

Drug: Abiraterone Acetate

Interventions

Abiraterone Acetate DRUG

Abiraterone acetate immediate release formulations

Prototype 1; Prototype 2; Prototype 3; Prototype 4 fasted; Prototype 4 fed; Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Age 18 to 55 years of age at the time of signing informed consent
• Expressed a desire not to father children in the near future (within 6 months of last IMP dose); males under 40 years of age must have been vasectomised
• Body mass index (BMI) of 18.5 to 30.0 kg/m2 as measured at screening
• Willing and able to communicate and participate in the whole study
• Provided written informed consent
• Agreed to adhere to the contraception requirements defined in Section 9.4 of the protocol

You may not qualify if:

• Subjects who received any IMP in a clinical research study within the 3 months or 90 days prior to Day 1 Period 1
• Males with a pregnant female partner
• Subjects were unable or unwilling to consume the standard high-fat breakfast (Part 2)
• Subjects were study site employees, or immediate family members of a study site or sponsor employee
• Subjects who had previously been enrolled in this study. Subjects who had taken part in Part 1 were not permitted to take part in Part 2
• History of any drug or alcohol abuse in the past 2 years prior to screening
• Regular alcohol consumption in males \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type) as confirmed by a repeat of the first positive alcohol breath test at screening or admission
• Current smokers and those who had smoked within the last 12 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm, as confirmed by repeat of the first test at screening or admission
• Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months prior to screening
• Subjects without suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
• Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator
• Serum potassium below the lower limit of the laboratory reference range at screening
• Alanine aminotransferase \>1.5× upper limit of laboratory reference range at screening
• Total bilirubin \>1.5× upper limit of laboratory reference range at screening
• Confirmed positive drugs of abuse test result

Sponsors & Collaborators

• Zentiva, k.s.: lead

Study Sites (1)

Quotient Sciences

Ruddington, United Kingdom

Location

MeSH Terms

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: June 25, 2019
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)