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A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants

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ClinicalTrials.gov Identifier: NCT01897389
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE July 9, 2013
First Posted Date  ICMJE July 12, 2013
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
  • Maximum plasma concentration of abiraterone [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2013)
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT) [ Time Frame: Up to 30 days after the last dose of study medication ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2013)
  • Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants
Official Title  ICMJE A Single-Dose, Open-Label, Randomized, 4-Period, 5-Treatment Crossover Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects
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.
Detailed Description This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 4-period, 5-treatment crossover study in order to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation. Approximately 32 healthy adult males will participate. The total study length is up to 68 days. This study will consist of a screening phase followed by an open-label treatment phase consisting of 4 single-dose treatment periods separated by a washout period of at least 7 days between dosing. Individuals will be randomly assigned to 1 of 8 treatment sequences. A single dose of 1000 mg abiraterone acetate will be given in each treatment period under fasted conditions. Participants will be confined to the study center from Day -1 of each treatment period until completion of the 96-hour blood sample collection on Day 5 of each treatment period. A follow-up visit will occur between 5 to 7 days after the last study procedure. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Treatment A
    1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions
  • Drug: Treatment B
    1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions
  • Drug: Treatment C
    1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions
  • Drug: Treatment D
    1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
  • Drug: Treatment E
    1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
Study Arms  ICMJE
  • Experimental: Sequence 1: abiraterone acetate
    Treatment sequence 1 is defined as: AEBD
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment D
    • Drug: Treatment E
  • Experimental: Sequence 2: abiraterone acetate
    Treatment sequence 2 is defined as: BACE
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
    • Drug: Treatment E
  • Experimental: Sequence 3: abiraterone acetate
    Treatment sequence 3 is defined as: CBDA
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
    • Drug: Treatment D
  • Experimental: Sequence 4: abiraterone acetate
    Treatment sequence 4 is defined as: EDAC
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment C
    • Drug: Treatment D
    • Drug: Treatment E
  • Experimental: Sequence 5: abiraterone acetate
    Treatment sequence 5 is defined as: DECA
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment C
    • Drug: Treatment D
    • Drug: Treatment E
  • Experimental: Sequence 6: abiraterone acetate
    Treatment sequence 6 is defined as: EADB
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment D
    • Drug: Treatment E
  • Experimental: Sequence 7: abiraterone acetate
    Treatment sequence 7 is defined as: ABEC
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
    • Drug: Treatment E
  • Experimental: Sequence 8: abiraterone acetate
    Treatment sequence 8 is defined as: BCAD
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
    • Drug: Treatment D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2013)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01897389
Other Study ID Numbers  ICMJE CR102353
212082PCR1010 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP