<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/NCT02211079</url>
  </required_header>
  <id_info>
    <org_study_id>CR105152</org_study_id>
    <secondary_id>54861911ALZ1010</secondary_id>
    <secondary_id>2014-001794-14</secondary_id>
    <nct_id>NCT02211079</nct_id>
  </id_info>
  <brief_title>A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates</brief_title>
  <official_title>An Open-Label, Fixed-Sequence Study in Healthy Male Subjects to Assess the Drug Interaction Potential of Multiple-Doses of JNJ-54861911 With a Drug &quot;Cocktail&quot; Representative for CYP3A4, CYP2B6, CYP2C9, and CYP1A2 Substrates</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 assess the effects of single and multiple once daily doses of&#xD;
      50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug enters&#xD;
      and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide in&#xD;
      healthy male participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, open-label (participants and researchers are aware about the&#xD;
      treatment, participants are receiving), fixed-sequence study in healthy male participants.&#xD;
      The study consists of 3 phases: Screening Phase (within 21 to 2 days prior to the first dose&#xD;
      administration on Day 1), Open Label Treatment Phase (Day 1 up to Day 9), and Follow-up Phase&#xD;
      (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal). The&#xD;
      maximum duration of study will be 7 weeks per participant. During the Open-Label Treatment&#xD;
      Phase, participants will receive JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from&#xD;
      Day 2 to Day 9 along with caffeine 100 mg (2*50 mg tablets), midazolam 2 mg (1 milliliter&#xD;
      [mL], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9. Blood&#xD;
      samples will be collected pre-dose (Day 1) up to Day 10 to understand the PK characteristics&#xD;
      of midazolam, 1-hydroxy midazolam (midazolam metabolite), caffeine, paraxanthine (caffeine&#xD;
      metabolite), tolbutamide, 4-hydroxytolbutamide and carboxytolbutamide (tolbutamide&#xD;
      metabolites). In addition, a blood sample will be collected on Day -1 from all enrolled&#xD;
      participants to study genetic factors that may influence the PK, safety, and/or tolerability&#xD;
      of JNJ-54861911 and co-medications. Participants' safety will be monitored throughout the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>The Cmax is the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Maximum Concentration (Tmax)</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>The Tmax is time to reach the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Last Quantifiable Plasma Concentration (Tlast)</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>The Tlast is time to last observed quantifiable plasma concentration (Clast).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - infinity])</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUC (0-last) and Clast/lambda(z), where AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24])</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination Half-Life (t1/2)</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, is calculated as 0.693 divided by lambda(z), where lambda(z) is first-order rate constant associated with the terminal portion of the curve. The t1/2 is the measure of time, for plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Elimination Rate Constant (lambda[z])</measure>
    <time_frame>Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)</time_frame>
    <description>Lambda(z) is first-order elimination rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to follow-up (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal)</time_frame>
    <description>An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>JNJ-54861911 + Caffeine + Midazolam +Tolbutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JNJ-54861911, 50 milligram (mg) (2*25 mg tablets) orally once daily from Day 2 to Day 9 along with caffeine 100 mg (2*50 mg tablets), midazolam 2 mg (1 milliliter [mL], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-54861911</intervention_name>
    <description>JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from Day 2 to Day 9.</description>
    <arm_group_label>JNJ-54861911 + Caffeine + Midazolam +Tolbutamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caffeine</intervention_name>
    <description>Single oral dose of caffeine 100 mg (2*50 mg tablets), on Day 1, 2, and 9.</description>
    <arm_group_label>JNJ-54861911 + Caffeine + Midazolam +Tolbutamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Single oral dose of midazolam 2 mg (1 mL, 2 mg/mL solution), on Day 1, 2, and 9.</description>
    <arm_group_label>JNJ-54861911 + Caffeine + Midazolam +Tolbutamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tolbutamide</intervention_name>
    <description>Single oral dose of Tolbutamide 500 mg tablet, on Day 1, 2, and 9.</description>
    <arm_group_label>JNJ-54861911 + Caffeine + Midazolam +Tolbutamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed an informed consent document indicating they understand the purpose of and&#xD;
             procedures required for the study, and are willing to participate in the study&#xD;
&#xD;
          -  Body mass index between 18 and 30 kilogram per square meter&#xD;
&#xD;
          -  Must be healthy on the basis of physical examination, medical history, vital signs,&#xD;
             and 12-lead electrocardiogram (ECG) performed at Screening or admission (up to Day 1&#xD;
             pre-dose)&#xD;
&#xD;
          -  Man, who is sexually active with a woman of child-bearing potential and has not had a&#xD;
             vasectomy, must agree to use an adequate contraception method as deemed appropriate by&#xD;
             the Investigator, and must also agree to not donate sperm during the study and for 90&#xD;
             days after receiving the last dose of study drug&#xD;
&#xD;
          -  Participant must be healthy on the basis of clinical laboratory tests performed at&#xD;
             Screening as per Investigator's judgment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current liver or renal insufficiency, closed-angle glaucoma, significant&#xD;
             cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic,&#xD;
             rheumatologic, psychiatric, dermatological or metabolic disturbances&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to JNJ-54861911 or its excipients,&#xD;
             sulfonamides, midazolam, caffeine or tolbutamide.&#xD;
&#xD;
          -  History of human immunodeficiency virus (HIV) antibody positive, or tests positive for&#xD;
             HIV at Screening&#xD;
&#xD;
          -  History of drug or alcohol abuse according to current Diagnostic and Statistical&#xD;
             Manual of Mental Disorders (DSM) criteria within 6 months before Screening or positive&#xD;
             test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates,&#xD;
             cocaine, cannabinoids, amphetamines, metamphetamines, benzodiazepines and cotinine) at&#xD;
             Screening or admission&#xD;
&#xD;
          -  Smoking of cigarettes (or equivalent) and/or used nicotine based products within 3&#xD;
             months prior to study drug administration&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>November 23, 2015</last_update_submitted>
  <last_update_submitted_qc>November 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>JNJ-54861911</keyword>
  <keyword>Caffeine</keyword>
  <keyword>Midazolam</keyword>
  <keyword>Tolbutamide</keyword>
  <keyword>Cytochrome P450 3A4</keyword>
  <keyword>Cytochrome P450 2C9</keyword>
  <keyword>Cytochrome P450 1A2</keyword>
  <keyword>Alzheimer's disease</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tolbutamide</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Caffeine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02211079
org study id: CR105152
secondary id: 54861911ALZ1010
secondary id: 2014-001794-14
nct id: NCT02211079
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effects of single and multiple once daily doses of
      50 milligram (mg) of JNJ-54861911 on pharmacokinetics (PK) (study of the way a drug enters
      and leaves the blood and tissues over time) of caffeine, midazolam, and tolbutamide in
      healthy male participants.
This is a single-center, open-label (participants and researchers are aware about the
      treatment, participants are receiving), fixed-sequence study in healthy male participants.
      The study consists of 3 phases: Screening Phase (within 21 to 2 days prior to the first dose
      administration on Day 1), Open Label Treatment Phase (Day 1 up to Day 9), and Follow-up Phase
      (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal). The
      maximum duration of study will be 7 weeks per participant. During the Open-Label Treatment
      Phase, participants will receive JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from
      Day 2 to Day 9 along with caffeine 100 mg (2*50 mg tablets), midazolam 2 mg (1 milliliter
      [mL], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9. Blood
      samples will be collected pre-dose (Day 1) up to Day 10 to understand the PK characteristics
      of midazolam, 1-hydroxy midazolam (midazolam metabolite), caffeine, paraxanthine (caffeine
      metabolite), tolbutamide, 4-hydroxytolbutamide and carboxytolbutamide (tolbutamide
      metabolites). In addition, a blood sample will be collected on Day -1 from all enrolled
      participants to study genetic factors that may influence the PK, safety, and/or tolerability
      of JNJ-54861911 and co-medications. Participants' safety will be monitored throughout the
      study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: The Cmax is the maximum observed plasma concentration.
measure: Time to Reach Maximum Concentration (Tmax)
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: The Tmax is time to reach the maximum observed plasma concentration.
measure: Time to Last Quantifiable Plasma Concentration (Tlast)
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: The Tlast is time to last observed quantifiable plasma concentration (Clast).
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: The AUC (0-last) is area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - infinity])
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUC (0-last) and Clast/lambda(z), where AUC (0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Time 24 Hours (AUC [0-24])
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: The AUC (0-24) is area under the plasma concentration-time curve from time zero to time 24 hours.
measure: Elimination Half-Life (t1/2)
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, is calculated as 0.693 divided by lambda(z), where lambda(z) is first-order rate constant associated with the terminal portion of the curve. The t1/2 is the measure of time, for plasma concentration to decrease by one half.
measure: Elimination Rate Constant (lambda[z])
time frame: Pre-dose on Day 1,2,3,9,10 and 0.5,1,1.5,2,2.5,3,4,6,8,10,12,16 hours post-dose on Day 1,2,9 (for Caffeine and Tolbutamide); Pre-dose on Day 1,9 and 0.5,1,1.5,2,2.5,3,4,6 hours post-dose on Day 1,2,9 (for Midazolam)
description: Lambda(z) is first-order elimination rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: Baseline up to follow-up (7 to 14 days after discharge from the study unit on Day 10 or at early withdrawal)
description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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: JNJ-54861911 + Caffeine + Midazolam +Tolbutamide
arm group type: Experimental
description: JNJ-54861911, 50 milligram (mg) (2*25 mg tablets) orally once daily from Day 2 to Day 9 along with caffeine 100 mg (2*50 mg tablets), midazolam 2 mg (1 milliliter [mL], 2 mg/mL solution), and tolbutamide 500 mg tablet, orally on Day 1, 2, and 9.
intervention type: Drug
intervention name: JNJ-54861911
description: JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from Day 2 to Day 9.
arm group label: JNJ-54861911 + Caffeine + Midazolam +Tolbutamide
intervention type: Drug
intervention name: Caffeine
description: Single oral dose of caffeine 100 mg (2*50 mg tablets), on Day 1, 2, and 9.
arm group label: JNJ-54861911 + Caffeine + Midazolam +Tolbutamide
intervention type: Drug
intervention name: Midazolam
description: Single oral dose of midazolam 2 mg (1 mL, 2 mg/mL solution), on Day 1, 2, and 9.
arm group label: JNJ-54861911 + Caffeine + Midazolam +Tolbutamide
intervention type: Drug
intervention name: Tolbutamide
description: Single oral dose of Tolbutamide 500 mg tablet, on Day 1, 2, and 9.
arm group label: JNJ-54861911 + Caffeine + Midazolam +Tolbutamide
criteria: 
gender: Male
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: Netherlands
responsible party type: Sponsor
mesh term: Tolbutamide
mesh term: Midazolam
mesh term: Caffeine