A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet

NCT01640093 | Completed Phase 1

• 2 other identifiers: CR100859212082PCR1006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.

Conditions

Healthy Participants

Keywords

Healthy participants; Bioavailability; Pharmacokinetics; Abiraterone acetate; Abiraterone

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet

  Pharmacokinetic parameter Cmax of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.

  For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours

• Area under the plasma concentration versus time curve (AUC) of abiraterone in coated, reformulated tablet compared to abiraterone in uncoated, current commercial tablet

  Pharmacokinetic parameter AUC of abiraterone (coated, reformulated tablet and uncoated, current commercial tablet) will be measured when abiraterone acetate is administered as a single oral 1000-mg dose.

  For each period: Predose, 15 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, and at 96 hours

Secondary Outcomes (1)

• Number of participants with adverse events

  Up to 68 days

Study Arms (4)

Treatment B

EXPERIMENTAL

Abiraterone acetate (500 mg), 2 coated, reformulated tablets.

Drug: Abiraterone acetate, 500 mg (coated, reformulated tablet)

Treatment C

EXPERIMENTAL

Abiraterone acetate (250 mg), 4 coated, reformulated tablets.

Drug: Abiraterone acetate, 250 mg (coated, reformulated tablet)

Treatment D

EXPERIMENTAL

Abiraterone acetate (500 mg), 2 coated, reformulated tablets, showing slower in vitro dissolution.

Drug: Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)

Treatment A

ACTIVE COMPARATOR

Abiraterone acetate (250 mg), 4 uncoated, current commercial tablets.

Drug: Abiraterone acetate, 250 mg (uncoated, current commercial tablet)

Interventions

Abiraterone acetate, 250 mg (uncoated, current commercial tablet) DRUG

Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.

Also known as: ZYTIGA

Treatment A

Abiraterone acetate, 500 mg (coated, reformulated tablet) DRUG

Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.

Also known as: ZYTIGA

Treatment B

Abiraterone acetate, 250 mg (coated, reformulated tablet) DRUG

Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.

Also known as: ZYTIGA

Treatment C

Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution) DRUG

Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.

Also known as: ZYTIGA

Treatment D

Eligibility Criteria

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

You may qualify if:

• Have body weight not less than 50 kg
• Must be a non-smoker, and has no history of smoking or use of nicotine-containing substances within the previous 2 months
• Must have blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
• Must have a 12-lead electrocardiogram consistent with normal cardiac conduction and function
• Must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study for 3 months after receiving the last dose of study medication

You may not qualify if:

• History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology or urinalysis (at screening)
• Clinically significant abnormal physical examination vital signs or 12-lead electrocardiogram (at screening)
• Usage of any prescription or nonprescription medication, except for acetaminophen, and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study medication is scheduled
• Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study medication)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

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: July 11, 2012
• First Posted: July 13, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

US (1)