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HealthyPhase 1NCT02117505

A Crossover Study to Evaluate Relative Bioavailability of Two JNJ-54781532 Tablet Formulations in Healthy Adult Participants

A Phase 1 study testing Formulation 2 and Formulation 1 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 evaluate the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test) compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed conditions at a single dose of 150 milligram… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Formulation 2 and Formulation 1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBelgium
Study dates
Apr 2014to Jun 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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female participants must be either: 1) not of childbearing potential: postmenopausal or surgically sterile at screening 2) of child-bearing potential: Must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening, and agree to use highly effective contraception throughout the study period, and for 90 days after final study drug administration. Women, who are not heterosexually active at Screening, must agree to utilize a highly-effective method of birth control if they become heterosexually active during their participation in the study
  • Must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day (-)1 of Period 1
  • Female participants must agree not to donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration
  • If a man who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 90 days after receiving the last dose of study drug
  • Participants eligible according to the following tuberculosis (TB) screening criteria: 1) following tuberculosis (TB) screening criteria 2) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination 3) have had no recent close contact with a person with active TB 4. Within 2 months prior to the first administration of study agent, have a negative T-spot or QuantiFERON-TB Gold test result

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, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection
  • Participant had major gastrointestinal (GI) surgery
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day (-) 1 of Period 1
  • Participant has an aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than or equal to (>=) the upper limit of normal (ULN)
  • History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 1 year before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day (-) 1 of Period 1

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Study site

    Merksem

Other trials in Belgium

About this study

Official title: A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Relative Bioavailability of Two JNJ-54781532 Tablet Formulations Under Fed Conditions in Healthy Adult Subjects

The purpose of this study is to evaluate the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-54781532 formulation 2 (test) compared with JNJ-54781532 formulation 1 (reference) in healthy participants under fed conditions at a single dose of 150 milligram (mg).

Read the detailed description

This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), 2-treatment, 2-period, 2-sequence crossover (participants may receive different interventions sequentially during the trial), and single-center study of JNJ-54781532. The duration of study will be approximately of 5 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (consists of 2 single-dose treatments, either JNJ-54781532 formulation 1 [reference] or JNJ-54781532 formulation 2 [test]), in subsequent 2-treatment periods, each separated with washout period of 7 days); and End-of-Study (done upon completion of the 72-hour pharmacokinetic sampling on Day 4 of Period 2, or at the time of early withdrawal). All the eligible participants will be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of the following treatments, one in each period. Followed by an overnight fast of at least 10 hours participants will be administered with study treatment 30 minutes after high-fat, high-calorie breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of two formulations of JNJ-54781532 (test and reference) will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions
Healthy
Being tested
Formulation 2, Formulation 1
Keywords
Biological Availability, JNJ-39220675, Healthy, Phase 1

What participants receive

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

  • Formulation 2Drug

    Also called JNJ-54781532 Test

    Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods.

  • Formulation 1Drug

    Also called JNJ-54781532 Reference

    Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5*30 mg tablet=150 mg) in one of the treatment periods.

Study groups in NCT02117505
Study groupRoleWhat they receive
Group 1 (Formulation 2 Then Formulation 1)ExperimentalSingle-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in first treatment period; followed by JNJ-54781532 formulation 1 as 150 mg orally (5*30 mg tablet=150 mg) in second treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Receives: Drug: Formulation 2; Drug: Formulation 1
Group 2 (Formulation 1 Then Formulation 2)ExperimentalSingle-dose of JNJ-54781532 formulation 1 will be administered as 150 mg oral tablet (5*30 mg tablet=150 mg) in first treatment period; followed by JNJ-54781532 formulation 2 as 150 mg oral tablet in second treatment period. A washout period of at least 7 days will be maintained between each treatment period.
Receives: Drug: Formulation 2; Drug: Formulation 1

What is being measured

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

  1. Maximum Plasma Concentration (Cmax) of JNJ-54781532

    The Cmax is the maximum observed plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  2. Time to Reach Maximum Concentration (tmax) of JNJ-54781532

    The tmax is time to reach the maximum observed plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-54781532

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

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-54781532

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

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

Secondary outcomes (6)

  1. Relative Bioavailability of JNJ-54781532

    Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Relative bioavailability of single-dose of two formulations of JNJ-54781532 will be compared in healthy participants under fed conditions.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  2. Time to last quantifiable plasma concentration (tlast) of JNJ-54781532

    The tlast is the time to last observed quantifiable plasma concentration.

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  3. Area Under the Plasma Concentration Percentage (%) Extrapolation of JNJ-54781532

    The percentage of AUC (0-infinity) that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100*(AUC [0-infinity] minus (AUC [0-last])/(AUC (0-infinity).

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  4. Elimination Half-Life (t [1/2] Lambda) of JNJ-54781532

    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, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  5. Rate Constant (Lambda[z])

    Lambda(z) is 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, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

  6. Adjusted Coefficient of Determination (R^2 adj)

    The coefficient of determination adjusted for the number of points used in the estimation of Lambda(z).

    Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1

Timeline

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

  1. First posted21 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2014
  4. Study completionJun 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117505
Sponsor's protocol ID
CR104088
Other IDs
54781532ARA1001
Status last verified
Jun 2014
First submitted
16 Apr 2014
Last updated
26 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Formulation 2 and Formulation 1 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 26 Jun 2014. 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 Belgium. 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 JNJ-54781532 (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, and 48 hours (h) post-dose of JNJ-54781532 on Day 1). The study lists 4 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 NCT02117505.

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 26 Jun 2014.

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