Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants

NCT02230046 | Completed Phase 1

• 2 other identifiers: CR105286212082PCR1007
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or drinking) conditions in healthy male participants.

Conditions

Healthy

Keywords

Healthy,; Abiraterone Acetate,; Bioequivalence.

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of abiraterone acetate

  The Cmax is the maximum observed plasma concentration of abiraterone acetate.

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

• Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of abiraterone acetate

  The AUC (0-last) is the area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration.

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

• Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC [0-infinity]) of abiraterone acetate

  The AUC (0-infinity) is the area under the plasma abiraterone acetate concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

Secondary Outcomes (6)

• Time to Reach the Maximum Plasma Concentration (Tmax) of abiraterone acetate

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

• Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC, ext) of abiraterone acetate

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

• Elimination Half-Life (t 1/2, Lambda) of abiraterone acetate

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

• Rate Constant (Lambda [z]) of abiraterone acetate

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

• Time to Last Quantifiable Plasma Concentration (T [last]) of abiraterone acetate

  Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period

Study Arms (6)

Sequence 1 (ABC)

EXPERIMENTAL

Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 1, Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 2 and Treatment C (new composition, 2\*500 mg coated tablets) in Period 3.

Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

Sequence 2 (BCA)

EXPERIMENTAL

Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 1, Treatment C (new composition, 2\*500 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 3.

Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

Sequence 3 (CAB)

EXPERIMENTAL

Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2\*500 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 2 and Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 3.

Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

Sequence 4 (ACB)

EXPERIMENTAL

Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 1, Treatment C (new composition, 2\*500 mg coated tablets) in Period 2 and Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 3.

Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

Sequence 5 (BAC)

EXPERIMENTAL

Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 1, Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 2 and Treatment C (new composition, 2\*500 mg coated tablets) in Period 3.

Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

Sequence 6 (CBA)

EXPERIMENTAL

Participants will receive a single oral 1000 milligram \[mg\] dose of abiraterone acetate in all 3 periods under fasted conditions as: Treatment C (new composition, 2\*500 mg coated tablets) in Period 1, Treatment B (current commercial formulation, 4\*250 mg coated tablets) in Period 2 and Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) in Period 3.

Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

Interventions

Abiraterone acetate (Treatment A) DRUG

Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4\*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.

Also known as: JNJ-212082

Sequence 1 (ABC); Sequence 2 (BCA); Sequence 3 (CAB); Sequence 4 (ACB); Sequence 5 (BAC); Sequence 6 (CBA)

Abiraterone acetate (Treatment B) DRUG

Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4\*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.

Also known as: JNJ-212082

Sequence 1 (ABC); Sequence 2 (BCA); Sequence 3 (CAB); Sequence 4 (ACB); Sequence 5 (BAC); Sequence 6 (CBA)

Eligibility Criteria

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

You may qualify if:

• If sexually active, participants must always use a condom during the study and for 1 week after last intake of study drug. If sexually active with a pregnant woman or woman of child-bearing potential, participants must agree to abstain from intercourse during the study and for 1 week after last intake of study drug. Participants should not donate sperm during the study and for 1 week after receiving the last dose of study drug
• Body mass index (BMI; weight \[kilogram(kg)\]/height\^2 \[meter square (m\^2)\]) between 18.5 and 30.0 kg/m\^2, (inclusive), and body weight not less than 50 kg
• Blood pressure (after the participants is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening as specified in the protocol
• Non-smoker, no history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participants or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology or clinical chemistry at Screening
• Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled through study completion
• History of, or a reason to believe a participants has a history of drug or alcohol abuse within the past 5 years

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: August 29, 2014
• First Posted: September 3, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)