NCT01897389

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

July 9, 2013

Last Update Submit

November 27, 2014

Conditions

Healthy Volunteers

Keywords

Healthy volunteersBioavailabilityAbiraterone acetateZYTIGA

Outcome Measures

Primary Outcomes (5)

  • Maximum plasma concentration of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

  • Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

  • Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

  • Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

  • Time to reach the maximum plasma concentration of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

Secondary Outcomes (1)

  • Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)

    Up to 30 days after the last dose of study medication

Other Outcomes (3)

  • Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

  • First-order rate constant associated with the terminal portion of the drug-concentration-time curve of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

  • Time to last quantifiable plasma concentration of abiraterone

    Periods 1-4 pharmacokinetic profile from Day 1 predose and postdose at 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h, 96 h

Study Arms (8)

Sequence 1: abiraterone acetate

EXPERIMENTAL

Treatment sequence 1 is defined as: AEBD

Drug: Treatment ADrug: Treatment BDrug: Treatment DDrug: Treatment E

Sequence 2: abiraterone acetate

EXPERIMENTAL

Treatment sequence 2 is defined as: BACE

Drug: Treatment ADrug: Treatment BDrug: Treatment CDrug: Treatment E

Sequence 3: abiraterone acetate

EXPERIMENTAL

Treatment sequence 3 is defined as: CBDA

Drug: Treatment ADrug: Treatment BDrug: Treatment CDrug: Treatment D

Sequence 4: abiraterone acetate

EXPERIMENTAL

Treatment sequence 4 is defined as: EDAC

Drug: Treatment ADrug: Treatment CDrug: Treatment DDrug: Treatment E

Sequence 5: abiraterone acetate

EXPERIMENTAL

Treatment sequence 5 is defined as: DECA

Drug: Treatment ADrug: Treatment CDrug: Treatment DDrug: Treatment E

Sequence 6: abiraterone acetate

EXPERIMENTAL

Treatment sequence 6 is defined as: EADB

Drug: Treatment ADrug: Treatment BDrug: Treatment DDrug: Treatment E

Sequence 7: abiraterone acetate

EXPERIMENTAL

Treatment sequence 7 is defined as: ABEC

Drug: Treatment ADrug: Treatment BDrug: Treatment CDrug: Treatment E

Sequence 8: abiraterone acetate

EXPERIMENTAL

Treatment sequence 8 is defined as: BCAD

Drug: Treatment ADrug: Treatment BDrug: Treatment CDrug: Treatment D

Interventions

Treatment ADRUG

1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions

Sequence 1: abiraterone acetateSequence 2: abiraterone acetateSequence 3: abiraterone acetateSequence 4: abiraterone acetateSequence 5: abiraterone acetateSequence 6: abiraterone acetateSequence 7: abiraterone acetateSequence 8: abiraterone acetate
Treatment BDRUG

1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions

Sequence 1: abiraterone acetateSequence 2: abiraterone acetateSequence 3: abiraterone acetateSequence 6: abiraterone acetateSequence 7: abiraterone acetateSequence 8: abiraterone acetate
Treatment CDRUG

1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions

Sequence 2: abiraterone acetateSequence 3: abiraterone acetateSequence 4: abiraterone acetateSequence 5: abiraterone acetateSequence 7: abiraterone acetateSequence 8: abiraterone acetate
Treatment DDRUG

1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions

Sequence 1: abiraterone acetateSequence 3: abiraterone acetateSequence 4: abiraterone acetateSequence 5: abiraterone acetateSequence 6: abiraterone acetateSequence 8: abiraterone acetate
Treatment EDRUG

1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions

Sequence 1: abiraterone acetateSequence 2: abiraterone acetateSequence 4: abiraterone acetateSequence 5: abiraterone acetateSequence 6: abiraterone acetateSequence 7: abiraterone acetate

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agrees to protocol-defined use of effective contraception for up to 1 week after receiving the last dose of study drug and agrees to not donate sperm during the study and for 1 week after receiving the last dose of study drug
  • Body mass index between 18.5 and 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
  • Blood pressure (after lying down for 5 minutes) between 90 and 140 mmHg systolic and no higher than 90 mmHg diastolic
  • A 12-lead electrocardiogram consistent with normal cardiac conduction and function
  • Non-smoker and no use of nicotine-containing substances within the previous 2 months
  • Laboratory values within protocol-defined parameters

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, 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 patient or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, or clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram at screening or at admission to the study center as deemed appropriate by the investigator
  • Screening serum testosterone level of \<200 ng/dL
  • Presence of sexual dysfunction 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 participant has a history of drug or alcohol abuse within the past 5 years
  • Positive test for drugs of abuse (such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens, or barbiturates) at screening and Day -1 of each treatment period
  • Known allergy to the study drug or any of the excipients of the formulation
  • History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (appendectomy and hernia repair will be allowed)
  • Donated blood or blood products or had substantial loss of blood within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
  • Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
  • Unable to swallow solid, oral dosage forms whole with the aid of water
  • Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibodies
  • Preplanned surgery or procedures that would interfere with the conduct of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

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 9, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

US(1)