<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/NCT03010059</url>
  </required_header>
  <id_info>
    <org_study_id>CR108251</org_study_id>
    <secondary_id>2016-004018-86</secondary_id>
    <secondary_id>64041575RSV1005</secondary_id>
    <nct_id>NCT03010059</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations</brief_title>
  <official_title>An Open-label, Randomized, 3-way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Single Dose of JNJ-64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by&#xD;
      measuring ALS-008112 plasma concentrations following administration of a single oral dose of&#xD;
      JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to&#xD;
      their respective current formulations under fasted conditions and to assess the effect of&#xD;
      food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy&#xD;
      adult participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">May 29, 2017</completion_date>
  <primary_completion_date type="Actual">May 29, 2017</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 Observed Plasma Concentration (Cmax) of ALS-008112 (JNJ-63549109)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Cmax is the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008112 (JNJ-63549109)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008112 (JNJ-63549109)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Concentration (Tmax) ALS-008112 (JNJ-63549109)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Tmax is defined as actual sampling time to reach maximum observed plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008112 (JNJ-63549109)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Elimination Half-life (t1/2term) of ALS-008112 (JNJ-63549109)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of ALS-008144 (JNJ-64167896)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Cmax is the maximum observed plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Concentration (Tmax) of ALS-008144 (JNJ-64167896)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Tmax defined as the actual sampling time to reach the maximum observed plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008144 (JNJ-64167896)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>AUC (0-last) defined as area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non-BQL]) concentration, calculated by linear trapezoidal summation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008144 (JNJ-64167896)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008144 (JNJ-64167896)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Elimination Half-life (t1/2term) of ALS-008144 (JNJ-64167896)</measure>
    <time_frame>Up to Day 8</time_frame>
    <description>The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Screening (28 days ) to Follow up Phase (10 to 14 days after last dose)</time_frame>
    <description>Safety and Tolerability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taste of JNJ-64041575 following administration of different oral suspension formulations under fed and fasted conditions in healthy adult participants in Panel 1 (taste questionnaire)</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants will complete a taste questionnaire within 5 to 15 minutes after study drug intake in each treatment period. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taste and Swallowability of JNJ-64041575 following administration of different oral tablet formulations under fed and fasted conditions in healthy adult participants in Panel 2 (taste and swallowability questionnaire)</measure>
    <time_frame>Day 1</time_frame>
    <description>A taste and swallowability questionnaire will be completed by the participant within 5 to 15 minutes after each study drug intake in each treatment period, to compare the taste and swallowability (tablets only) of JNJ-64041575 following administration of different oral formulations under fed and fasted conditions. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'. For the swallowability, a dichotomization will be made of 'slightly difficult' or worse versus 'neither difficult nor easy' or better. The results of the questionnaire will be transcribed into the e-Source by a member of the study-site personnel.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Panel 1: Treatment ABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 240 milligram (mg) JNJ-64041575 as 6.0 milliliter (mL) of a 40-milligram per milliliter (mg/mL) current oral suspension formulation (reference 1) under fasted conditions (Treatment A) in period 1, then 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 1) under fasted conditions (Treatment B) in period 2 followed by 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 2) under fed conditions (Treatment C) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Treatment BCA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (test 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Treatment CAB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C (test 2) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Treatment ACB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (reference 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Treatment BAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (test 1) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment C (test 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 1: Treatment CBA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment C (test 2) in period 1, then Treatment B (test 1) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Treatment DEF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64041575 as 1 tablet of the 250-mg current oral tablet formulation (reference 2) under fasted conditions (Treatment D) in period 1, then 1 tablet of the 250-mg new concept oral tablet formulation (test 3) under fasted conditions (Treatment E) in period 2 followed by 1 tablet of the 250-mg new concept oral tablet formulation (test 4) under fed conditions (Treatment F) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Treatment EFD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment E (test 3) in period 1, then Treatment F (test 4) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Treatment FDE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment F (test 4) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment E (test 3) then in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Treatment DFE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment D (reference 2) in period 1, then Treatment F (test 4) in period 2 followed by Treatment E (test 3) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Treatment EDF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment E (test 3) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment F (test 4) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panel 2: Treatment FED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment F (test 4) in period 1, then Treatment E (test 3) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64041575 (oral suspension formulation)</intervention_name>
    <description>Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation.</description>
    <arm_group_label>Panel 1: Treatment ABC</arm_group_label>
    <arm_group_label>Panel 1: Treatment ACB</arm_group_label>
    <arm_group_label>Panel 1: Treatment BAC</arm_group_label>
    <arm_group_label>Panel 1: Treatment BCA</arm_group_label>
    <arm_group_label>Panel 1: Treatment CAB</arm_group_label>
    <arm_group_label>Panel 1: Treatment CBA</arm_group_label>
    <other_name>ALS-008176</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64041575 (oral tablet formulation )</intervention_name>
    <description>Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation.</description>
    <arm_group_label>Panel 2: Treatment DEF</arm_group_label>
    <arm_group_label>Panel 2: Treatment DFE</arm_group_label>
    <arm_group_label>Panel 2: Treatment EDF</arm_group_label>
    <arm_group_label>Panel 2: Treatment EFD</arm_group_label>
    <arm_group_label>Panel 2: Treatment FDE</arm_group_label>
    <arm_group_label>Panel 2: Treatment FED</arm_group_label>
    <other_name>ALS-008176</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have a body mass index (BMI; weight in kg divided by the square of&#xD;
             height in meters) between 18.0 and 30.0 kilogram per square meter kg/m^2, extremes&#xD;
             included, and a body weight not less than 50.0 kg, extremes included&#xD;
&#xD;
          -  Participant must have a normal 12-lead electrocardiogram (ECG) consistent with normal&#xD;
             cardiac conduction and function at screening, including: a) normal sinus rhythm (heart&#xD;
             rate between 45 and 100 beats per minute [bpm], extremes included); b) QT corrected&#xD;
             according to Fridericia's formula (QTcF) interval less than or equal to (&lt;=)430&#xD;
             milliseconds (ms) for male participants and &lt;=450 ms for female participants; c) QRS&#xD;
             interval &lt;=110 ms; d) PR interval &lt;=200 ms; e) ECG morphology consistent with healthy&#xD;
             cardiac conduction and function. Any evidence of heart block, or of left or right&#xD;
             bundle branch block is exclusionary&#xD;
&#xD;
          -  Participants must have normal values for alanine aminotransferase (ALT) and aspartate&#xD;
             aminotransferase (AST) (less than or equal (&lt;=)1.0×upper limit of laboratory normal&#xD;
             range [ULN])&#xD;
&#xD;
          -  Contraceptive use by female participants should be consistent with local regulations&#xD;
             regarding the use of contraceptive methods for participants participating in clinical&#xD;
             studies. Before randomization, a woman must be either: a) Not of childbearing&#xD;
             potential defined as: 1) Postmenopausal: A postmenopausal state is defined as greater&#xD;
             than (&gt;)45 years and no menses for 12 consecutive months without an alternative&#xD;
             medical cause and a serum follicle stimulating hormone (FSH) level in the&#xD;
             postmenopausal range (&gt;40 International units per liter [IU/L] or milli-international&#xD;
             units per milliliter [mIU/mL]), OR; 2) Permanently sterile: Permanent sterilization&#xD;
             methods include hysterectomy, bilateral salpingectomy, bilateral tubal&#xD;
             occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy&#xD;
             b) Of childbearing potential and, if heterosexually active, 1) Practicing a highly&#xD;
             effective method of contraception (failure rate of less than (&lt;)1percent (%) per year&#xD;
             when used consistently and correctly) 2) Agrees to remain on a highly effective method&#xD;
             throughout the study and for at least 44 days after the last dose of study drug&#xD;
&#xD;
          -  A female participant, except if postmenopausal, must have a negative serum beta human&#xD;
             chorionic gonadotropin (beta- hCG) pregnancy test at screening, and a negative urine&#xD;
             pregnancy test on Day 1 in each treatment period&#xD;
&#xD;
          -  Participant must be able to taste and smell normally, to their own opinion.&#xD;
             Participants who have an impaired sense of taste and/or smell due to any conditions&#xD;
             such as allergic rhinitis, common cold, or sinusitis are not eligible to take part in&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a mouth pathology including, but not limited to, pain, ulcer, edema,&#xD;
             mucosal erosion, gingivitis and/or (dental) abscesses, or receives treatment for oral&#xD;
             pathologies (eg, antifungals or antibiotics) or oral treatment for any disease&#xD;
&#xD;
          -  Participant with a history of clinically significant drug allergy such as, but not&#xD;
             limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous&#xD;
             studies with experimental drugs&#xD;
&#xD;
          -  Participant is hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV)&#xD;
             antibody positive with HCV RNA positive, or has another clinically active liver&#xD;
             disease at screening&#xD;
&#xD;
          -  Participant has a history of human immunodeficiency virus type 1 (HIV-1) or HIV 2&#xD;
             antibody positive, or tests positive for HIV-1 or -2 at screening&#xD;
&#xD;
          -  Participant has previously been dosed with JNJ-64041575 in more than 3 single-dose&#xD;
             studies with JNJ-64041575 or has previously been dosed with JNJ-64041575 in a&#xD;
             multiple-dose study with JNJ-64041575&#xD;
&#xD;
          -  Participants with 1 or more of the following laboratory abnormalities at screening as&#xD;
             defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity&#xD;
             Table a) Serum creatinine grade 1 or greater (greater [&gt;]1.0* upper limit of&#xD;
             laboratory normal range [ULN]) b) Hemoglobin grade 1 or greater (&lt;=10.5 gram per&#xD;
             decilitre [g/dL]) c) Platelet count grade 1 or greater (&lt;=99.999/millimeter [mm]^3) d)&#xD;
             Reticulocyte count (absolute) below the lower limit of laboratory normal range (LLN)&#xD;
             e) Absolute neutrophil count grade 1 or greater (&lt;=1,500/mm^3) f) Total bilirubin&#xD;
             grade 1 or greater (&gt;1.0*ULN) g) Any other toxicity grade 2 or above, except for grade&#xD;
             2 elevations of low density lipoprotein (LDL) cholesterol and/or cholesterol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>
      <name>Clinical Pharmacology Unit</name>
      <address>
        <city>Merksem</city>
        <zip>2170</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03010059
org study id: CR108251
secondary id: 2016-004018-86
secondary id: 64041575RSV1005
nct id: NCT03010059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by
      measuring ALS-008112 plasma concentrations following administration of a single oral dose of
      JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to
      their respective current formulations under fasted conditions and to assess the effect of
      food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy
      adult participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax) of ALS-008112 (JNJ-63549109)
time frame: Up to Day 8
description: Cmax is the maximum observed plasma concentration.
measure: Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008112 (JNJ-63549109)
time frame: Up to Day 8
description: Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non BQL]) concentration, calculated by linear trapezoidal summation.
measure: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008112 (JNJ-63549109)
time frame: Up to Day 8
description: 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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
measure: Time to Reach Maximum Concentration (Tmax) ALS-008112 (JNJ-63549109)
time frame: Up to Day 8
description: Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
measure: Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008112 (JNJ-63549109)
time frame: Up to Day 8
description: Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.
measure: Apparent Terminal Elimination Half-life (t1/2term) of ALS-008112 (JNJ-63549109)
time frame: Up to Day 8
description: The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).
measure: Maximum Observed Plasma Concentration (Cmax) of ALS-008144 (JNJ-64167896)
time frame: Up to Day 8
description: Cmax is the maximum observed plasma concentration.
measure: Time to Reach Maximum Concentration (Tmax) of ALS-008144 (JNJ-64167896)
time frame: Up to Day 8
description: Tmax defined as the actual sampling time to reach the maximum observed plasma concentration.
measure: Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008144 (JNJ-64167896)
time frame: Up to Day 8
description: AUC (0-last) defined as area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit [non-BQL]) concentration, calculated by linear trapezoidal summation.
measure: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008144 (JNJ-64167896)
time frame: Up to Day 8
description: 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 (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
measure: Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008144 (JNJ-64167896)
time frame: Up to Day 8
description: Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.
measure: Apparent Terminal Elimination Half-life (t1/2term) of ALS-008144 (JNJ-64167896)
time frame: Up to Day 8
description: The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda[z]).
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Screening (28 days ) to Follow up Phase (10 to 14 days after last dose)
description: Safety and Tolerability
measure: Taste of JNJ-64041575 following administration of different oral suspension formulations under fed and fasted conditions in healthy adult participants in Panel 1 (taste questionnaire)
time frame: Day 1
description: Participants will complete a taste questionnaire within 5 to 15 minutes after study drug intake in each treatment period. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'.
measure: Taste and Swallowability of JNJ-64041575 following administration of different oral tablet formulations under fed and fasted conditions in healthy adult participants in Panel 2 (taste and swallowability questionnaire)
time frame: Day 1
description: A taste and swallowability questionnaire will be completed by the participant within 5 to 15 minutes after each study drug intake in each treatment period, to compare the taste and swallowability (tablets only) of JNJ-64041575 following administration of different oral formulations under fed and fasted conditions. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'. For the swallowability, a dichotomization will be made of 'slightly difficult' or worse versus 'neither difficult nor easy' or better. The results of the questionnaire will be transcribed into the e-Source by a member of the study-site personnel.
arm group label: Panel 1: Treatment ABC
arm group type: Experimental
description: Participants will receive 240 milligram (mg) JNJ-64041575 as 6.0 milliliter (mL) of a 40-milligram per milliliter (mg/mL) current oral suspension formulation (reference 1) under fasted conditions (Treatment A) in period 1, then 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 1) under fasted conditions (Treatment B) in period 2 followed by 4.0 mL of a 60-mg/mL new concept oral suspension formulation (test 2) under fed conditions (Treatment C) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 1: Treatment BCA
arm group type: Experimental
description: Participants will receive Treatment B (test 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 1: Treatment CAB
arm group type: Experimental
description: Participants will receive Treatment C (test 2) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 1: Treatment ACB
arm group type: Experimental
description: Participants will receive Treatment A (reference 1) in period 1, then Treatment C (test 2) in period 2 followed by Treatment B (test 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 1: Treatment BAC
arm group type: Experimental
description: Participants will receive Treatment B (test 1) in period 1, then Treatment A (reference 1) in period 2 followed by Treatment C (test 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 1: Treatment CBA
arm group type: Experimental
description: Participants will receive Treatment C (test 2) in period 1, then Treatment B (test 1) in period 2 followed by Treatment A (reference 1) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 2: Treatment DEF
arm group type: Experimental
description: Participants will receive JNJ-64041575 as 1 tablet of the 250-mg current oral tablet formulation (reference 2) under fasted conditions (Treatment D) in period 1, then 1 tablet of the 250-mg new concept oral tablet formulation (test 3) under fasted conditions (Treatment E) in period 2 followed by 1 tablet of the 250-mg new concept oral tablet formulation (test 4) under fed conditions (Treatment F) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 2: Treatment EFD
arm group type: Experimental
description: Participants will receive Treatment E (test 3) in period 1, then Treatment F (test 4) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 2: Treatment FDE
arm group type: Experimental
description: Participants will receive Treatment F (test 4) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment E (test 3) then in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 2: Treatment DFE
arm group type: Experimental
description: Participants will receive Treatment D (reference 2) in period 1, then Treatment F (test 4) in period 2 followed by Treatment E (test 3) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 2: Treatment EDF
arm group type: Experimental
description: Participants will receive Treatment E (test 3) in period 1, then Treatment D (reference 2) in period 2 followed by Treatment F (test 4) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
arm group label: Panel 2: Treatment FED
arm group type: Experimental
description: Participants will receive Treatment F (test 4) in period 1, then Treatment E (test 3) in period 2 followed by Treatment D (reference 2) in period 3 on Day 1. There will be a washout period of at least 14 days between study drug intake in subsequent treatment periods.
intervention type: Drug
intervention name: JNJ-64041575 (oral suspension formulation)
description: Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation.
arm group label: Panel 1: Treatment ABC
arm group label: Panel 1: Treatment ACB
arm group label: Panel 1: Treatment BAC
arm group label: Panel 1: Treatment BCA
arm group label: Panel 1: Treatment CAB
arm group label: Panel 1: Treatment CBA
other name: ALS-008176
intervention type: Drug
intervention name: JNJ-64041575 (oral tablet formulation )
description: Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation.
arm group label: Panel 2: Treatment DEF
arm group label: Panel 2: Treatment DFE
arm group label: Panel 2: Treatment EDF
arm group label: Panel 2: Treatment EFD
arm group label: Panel 2: Treatment FDE
arm group label: Panel 2: Treatment FED
other name: ALS-008176
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 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