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HealthyPhase 1NCT02230046

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

A Phase 1 study testing Abiraterone acetate (Treatment A) and Abiraterone acetate (Treatment B) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Abiraterone acetate (Treatment A) and Abiraterone acetate (Treatment B)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteUnited States
Study dates
Oct 2014to Nov 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Tempe, Arizona

Other trials in United States

About this study

Official title: A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Abiraterone Acetate Coated Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Uncoated Tablet Formulation Under Fasted Conditions in Healthy Male Subjects

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.

Read the detailed description

This is a Phase 1, randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, single-dose and 3-way Crossover (the same medications provided to all participants but in different sequence) pivotal study to determine the bioequivalence of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated tablet formulation. Approximately 102 healthy male participants will participate in this study. Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (within 21 days before the first study drug administration of the first period), an open-label treatment Phase consisting of 3 single-dose treatment periods (45 days) and follow-up Phase (5 to 7 days after the last study procedure). The total study duration for each participant will be from 45 days to a maximum of 61 days. Participants will receive a single oral 1000 milligram (mg) dose of abiraterone acetate under fasted conditions either as Treatment A (current commercial formulation, uncoated), Treatment B (current commercial formulation, coated) or Treatment C (new composition, coated). Bioequivalence will be primarily evaluated by pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Conditions
Healthy
Being tested
Abiraterone acetate (Treatment A), Abiraterone acetate (Treatment B)
Keywords
Healthy,, Abiraterone Acetate,, Bioequivalence.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone acetate (Treatment A)Drug

    Also called JNJ-212082

    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.

  • Abiraterone acetate (Treatment B)Drug

    Also called JNJ-212082

    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.

  • Abiraterone acetate (Treatment B)Drug

    Also called JNJ-212082

    Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.

Study groups in NCT02230046
Study groupRoleWhat they receive
Sequence 1 (ABC)ExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)
Sequence 2 (BCA)ExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)
Sequence 3 (CAB)ExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)
Sequence 4 (ACB)ExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)
Sequence 5 (BAC)ExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)
Sequence 6 (CBA)ExperimentalParticipants 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.
Receives: Drug: Abiraterone acetate (Treatment A); Drug: Abiraterone acetate (Treatment B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Plasma Concentration (Cmax) of abiraterone acetate

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

    Measured: 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

  2. 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.

    Measured: 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

  3. 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.

    Measured: 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)

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

    The Tmax is the time to reach the maximum observed plasma concentration of abiraterone acetate.

    Measured: 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

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

    Percentage of area under the plasma abiraterone acetate concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC, ext) is calculated using formula: ((AUC [0-infinity] minus- AUC [0-last)]/AUC [0-infinity])*100.

    Measured: 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

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

    Elimination half-life (t 1/2, Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

    Measured: 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

  4. Rate Constant (Lambda [z]) of abiraterone acetate

    Lambda (z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

    Measured: 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

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

    Time to last quantifiable plasma concentration of abiraterone acetate will be observed.

    Measured: 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

  6. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: Screening up to follow-up (5 to 7 days after last dose administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02230046
Sponsor's protocol ID
CR105286
Other IDs
212082PCR1007
Status last verified
Jan 2016
First submitted
29 Aug 2014
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abiraterone acetate (Treatment A) and Abiraterone acetate (Treatment B) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of abiraterone acetate (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.

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