<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02260700</url>
  </required_header>
  <id_info>
    <org_study_id>CR102380</org_study_id>
    <secondary_id>54861911ALZ1003</secondary_id>
    <secondary_id>2013-002650-70</secondary_id>
    <nct_id>NCT02260700</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male Participants</brief_title>
  <official_title>A Randomized, Open-Label, 3-Way Crossover Study in Healthy Older Male Subjects to Evaluate the Bioavailability, Food Effect, Safety and Tolerability of A Solid Dosage Formulation of JNJ-54861911</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine pharmacokinetics (the study of the way a drug&#xD;
      enters and leaves the blood and tissues over time) and the relative-bioavailability (the&#xD;
      extent to which a drug or other substance becomes available to the body) of JNJ-54861911&#xD;
      solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy&#xD;
      older male participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (study medication assigned to participants by chance), open-label (all&#xD;
      people know the identity of the intervention), single-center, single-dose and 3-way Crossover&#xD;
      (the same medications provided to all participants but in different sequence) study to&#xD;
      determine the bioavailability of JNJ-54861911 solid dosage formulation in healthy older male&#xD;
      participants. The study will consist of 3 parts: Screening Phase (that is, 28 days before&#xD;
      study commences on Day 1), an open-label treatment Phase (consists of 3 single-dose treatment&#xD;
      periods, either a single oral suspension formulation [Treatment A] or solid formulation 25&#xD;
      milligram (mg) dose of JNJ-54861911 under fasted [Treatment B] or fed conditions [Treatment&#xD;
      C] in subsequent 3-treatment periods; each treatment period separated with washout period of&#xD;
      6 days) and follow-up Phase (7 to 14 days after last dose administration). The maximal study&#xD;
      duration for a participant will not exceed 8 weeks. All the eligible participants will be&#xD;
      randomly assigned to 1 of the 6 treatment sequences. Followed by an overnight fast of at&#xD;
      least 10 hours participants will be administered with study treatment under fasted condition&#xD;
      or fed condition (30 minutes after high-fat, high-calorie breakfast). Participants will not&#xD;
      be allowed to have food until 4 hours of drug administration. Blood samples will be collected&#xD;
      for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.&#xD;
      Bioavailability will be primarily evaluated by pharmacokinetic parameters. Participants'&#xD;
      safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The Cmax is the maximum observed plasma concentration of JNJ-54861911.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The AUC (0-t) calculated by trapezoidal summation [time t is the time of the last quantifiable concentration (C[last])].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The AUC (0-infinity) is the area under the plasma JNJ-54861911concentration-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 JNJ-54861911 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination Rate Constant (Lambda [z]) of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Half-life (t[1/2]) of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>The t(1/2) is defined as 0.693/Lambda (z).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative Bioavailability (F[rel]) of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Absorption of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Rate of absorption will be measured using the peak concentration of JNJ-54861911 (following administration of solid dosage form and suspension dosage form) under fasted conditions and fed conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extent of Absorption of JNJ-54861911</measure>
    <time_frame>Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period</time_frame>
    <description>Extent of absorption will be measured under fasted conditions and fed conditions, using the area under plasma concentrations of JNJ-54861911 versus time from time 0 to the last sample point (AUC[0-t]) and from time 0 to infinity (AUC[0-inf]).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events (AEs) and Serious AEs</measure>
    <time_frame>Screening up to follow-up (7 to 14 days after last dose administration)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2 (ACB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3 (BAC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed by Treatment A (single oral dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 4 (BCA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed byTreatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 5 (CAB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-54861911 (Treatment A)</intervention_name>
    <description>Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (ACB)</arm_group_label>
    <arm_group_label>Sequence 3 (BAC)</arm_group_label>
    <arm_group_label>Sequence 4 (BCA)</arm_group_label>
    <arm_group_label>Sequence 5 (CAB)</arm_group_label>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-54861911 (Treatment B)</intervention_name>
    <description>Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (ACB)</arm_group_label>
    <arm_group_label>Sequence 3 (BAC)</arm_group_label>
    <arm_group_label>Sequence 4 (BCA)</arm_group_label>
    <arm_group_label>Sequence 5 (CAB)</arm_group_label>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-54861911 (Treatment C)</intervention_name>
    <description>Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods.</description>
    <arm_group_label>Sequence 1 (ABC)</arm_group_label>
    <arm_group_label>Sequence 2 (ACB)</arm_group_label>
    <arm_group_label>Sequence 3 (BAC)</arm_group_label>
    <arm_group_label>Sequence 4 (BCA)</arm_group_label>
    <arm_group_label>Sequence 5 (CAB)</arm_group_label>
    <arm_group_label>Sequence 6 (CBA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between 18&#xD;
             and 30 kg/m^2, (inclusive)&#xD;
&#xD;
          -  Be healthy for their age group with or without medication on the basis of physical&#xD;
             examination, medical history, vital signs, and 12-lead electrocardiogram (ECG)&#xD;
             performed at Screening or admission. Minor deviations in ECG, which are not considered&#xD;
             to be of clinical significance to the investigator, are acceptable&#xD;
&#xD;
          -  Be healthy on the basis of clinical laboratory tests performed at Screening. If the&#xD;
             results of the serum chemistry panel [including liver enzymes], hematology, or&#xD;
             urinalysis are outside the normal reference ranges, the participant may be included&#xD;
             only if the investigator judges the abnormalities or deviations from normal to be not&#xD;
             clinically significant. This determination must be recorded in the participants'&#xD;
             source documents and initialed by the investigator&#xD;
&#xD;
          -  Men who are sexually active with a woman of childbearing potential and have not had a&#xD;
             vasectomy must agree to use a barrier method of birth control for example, either&#xD;
             condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap&#xD;
             (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository,&#xD;
             and all men must also not donate sperm during the study and for 3 months after&#xD;
             receiving the last dose of study drug. In addition, their female partners should also&#xD;
             use an appropriate method of birth control for at least the same duration&#xD;
&#xD;
          -  Participants' must have signed an informed consent document indicating that they&#xD;
             understand the purpose of and procedures required for the study and are willing to&#xD;
             participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a clinically significant abnormal physical examination, vital signs or&#xD;
             12 lead ECG (including QTc greater than (&gt;) 450msec, Left Bundle Branch Block,&#xD;
             permanent pacemaker or implantable cardioverter defibrillator) at Screening or&#xD;
             admission&#xD;
&#xD;
          -  Participant has a history of or current liver or renal insufficiency; significant&#xD;
             cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic,&#xD;
             rheumatologic, psychiatric, or metabolic disturbances&#xD;
&#xD;
          -  Use of any prescription or over-the-counter medication, herbal medication, vitamins,&#xD;
             or mineral supplements within 14 days prior to study drug administration (not&#xD;
             including paracetamol). Medication for chronic use in age related disease will be&#xD;
             allowed after approval by both the investigator and to the sponsor. No change in dose&#xD;
             or regimen will be permitted during the study that is, from the Screening visit until&#xD;
             the follow-up visit&#xD;
&#xD;
          -  Participant has a history of spontaneous, prolonged or severe bleeding of unclear&#xD;
             origin&#xD;
&#xD;
          -  Participant has a history of epilepsy or fits or unexplained black-outs other than&#xD;
             vasovagal collapse&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Merksem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>JNJ-54861911</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260700
org study id: CR102380
secondary id: 54861911ALZ1003
secondary id: 2013-002650-70
nct id: NCT02260700
lead sponsor: 
has dmc: No
The purpose of this study is to determine pharmacokinetics (the study of the way a drug
      enters and leaves the blood and tissues over time) and the relative-bioavailability (the
      extent to which a drug or other substance becomes available to the body) of JNJ-54861911
      solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy
      older male participants.
This is a 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) study to
      determine the bioavailability of JNJ-54861911 solid dosage formulation in healthy older male
      participants. The study will consist of 3 parts: Screening Phase (that is, 28 days before
      study commences on Day 1), an open-label treatment Phase (consists of 3 single-dose treatment
      periods, either a single oral suspension formulation [Treatment A] or solid formulation 25
      milligram (mg) dose of JNJ-54861911 under fasted [Treatment B] or fed conditions [Treatment
      C] in subsequent 3-treatment periods; each treatment period separated with washout period of
      6 days) and follow-up Phase (7 to 14 days after last dose administration). The maximal study
      duration for a participant will not exceed 8 weeks. All the eligible participants will be
      randomly assigned to 1 of the 6 treatment sequences. Followed by an overnight fast of at
      least 10 hours participants will be administered with study treatment under fasted condition
      or fed condition (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.
      Bioavailability will be primarily evaluated by pharmacokinetic parameters. Participants'
      safety will be monitored throughout the study.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax) of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The Cmax is the maximum observed plasma concentration of JNJ-54861911.
measure: Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The Tmax is the time to reach the maximum observed plasma concentration of JNJ-54861911.
measure: Area Under the Plasma Concentration-Time Curve From 0 to t Hours (AUC[0-t]) Post Dose of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The AUC (0-t) calculated by trapezoidal summation [time t is the time of the last quantifiable concentration (C[last])].
measure: Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The AUC (0-infinity) is the area under the plasma JNJ-54861911concentration-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 JNJ-54861911 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.
measure: Elimination Rate Constant (Lambda [z]) of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
measure: Terminal Half-life (t[1/2]) of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: The t(1/2) is defined as 0.693/Lambda (z).
measure: Relative Bioavailability (F[rel]) of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Relative bioavailability, calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).
measure: Rate of Absorption of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Rate of absorption will be measured using the peak concentration of JNJ-54861911 (following administration of solid dosage form and suspension dosage form) under fasted conditions and fed conditions.
measure: Extent of Absorption of JNJ-54861911
time frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose on Day 1 of each period
description: Extent of absorption will be measured under fasted conditions and fed conditions, using the area under plasma concentrations of JNJ-54861911 versus time from time 0 to the last sample point (AUC[0-t]) and from time 0 to infinity (AUC[0-inf]).
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
time frame: Screening up to follow-up (7 to 14 days after last dose administration)
description: 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.
arm group label: Sequence 1 (ABC)
arm group type: Experimental
description: Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.
arm group label: Sequence 2 (ACB)
arm group type: Experimental
description: Participants will receive Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 1; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment B (single oral dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.
arm group label: Sequence 3 (BAC)
arm group type: Experimental
description: Participants will receive Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed by Treatment A (single oral dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment C (single oral dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.
arm group label: Sequence 4 (BCA)
arm group type: Experimental
description: Participants will receive Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 1; followed byTreatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.
arm group label: Sequence 5 (CAB)
arm group type: Experimental
description: Participants will receive Treatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 2; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.
arm group label: Sequence 6 (CBA)
arm group type: Experimental
description: Participants will receive Treatment C (single dose of JNJ-54861911 25 mg solid formulation under fed conditions) in Period 1; followed by Treatment B (single dose of JNJ-54861911 25 mg solid formulation under fasted conditions) in Period 2; followed by Treatment A (single dose of JNJ-54861911 25 milligram (mg) oral suspension formulation under fasted conditions) in Period 3. A washout period of at least 6 days will be maintained between each treatment period.
intervention type: Drug
intervention name: JNJ-54861911 (Treatment A)
description: Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (ACB)
arm group label: Sequence 3 (BAC)
arm group label: Sequence 4 (BCA)
arm group label: Sequence 5 (CAB)
arm group label: Sequence 6 (CBA)
intervention type: Drug
intervention name: JNJ-54861911 (Treatment B)
description: Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (ACB)
arm group label: Sequence 3 (BAC)
arm group label: Sequence 4 (BCA)
arm group label: Sequence 5 (CAB)
arm group label: Sequence 6 (CBA)
intervention type: Drug
intervention name: JNJ-54861911 (Treatment C)
description: Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods.
arm group label: Sequence 1 (ABC)
arm group label: Sequence 2 (ACB)
arm group label: Sequence 3 (BAC)
arm group label: Sequence 4 (BCA)
arm group label: Sequence 5 (CAB)
arm group label: Sequence 6 (CBA)
criteria: 
gender: Male
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: Belgium
responsible party type: Sponsor