<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/NCT03249402</url>
  </required_header>
  <id_info>
    <org_study_id>CR108351</org_study_id>
    <secondary_id>2016-004725-16</secondary_id>
    <secondary_id>42847922MDD1003</secondary_id>
    <nct_id>NCT03249402</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants</brief_title>
  <official_title>An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</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 evaluate the effect of multiple 40 milligram (mg) doses of&#xD;
      JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination&#xD;
      oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy&#xD;
      female adult partcipants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">November 24, 2017</completion_date>
  <primary_completion_date type="Actual">November 24, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) in Cycle 1</measure>
    <time_frame>Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose</time_frame>
    <description>The Cmax is the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) in Cycle 2</measure>
    <time_frame>Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose</time_frame>
    <description>The Cmax is the maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough Plasma Concentration (Ctrough) in Cycle 1</measure>
    <time_frame>Cycle1: Predose (Day 21)</time_frame>
    <description>The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough Plasma Concentration (Ctrough) in Cycle 2</measure>
    <time_frame>Cycle 2: Predose (Day 21)</time_frame>
    <description>The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1</measure>
    <time_frame>Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose</time_frame>
    <description>The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2</measure>
    <time_frame>Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose</time_frame>
    <description>The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to 87 Days</time_frame>
    <description>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Oral Contraceptive Tablet + JNJ-42847922</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethinyl Estradiol + Levonorgestrel</intervention_name>
    <description>Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.</description>
    <arm_group_label>Oral Contraceptive Tablet + JNJ-42847922</arm_group_label>
    <other_name>Microgynon 30</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-42847922</intervention_name>
    <description>Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.</description>
    <arm_group_label>Oral Contraceptive Tablet + JNJ-42847922</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be female of childbearing potential (women with tubal ligation are not accepted)&#xD;
&#xD;
          -  Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23&#xD;
             within the range of 18 to 30 kilogram / square meter (kg/m^2) inclusive&#xD;
&#xD;
          -  Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg),&#xD;
             inclusive, and diastolic blood pressure no higher than 90 mmHg&#xD;
&#xD;
          -  Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days&#xD;
             after receiving the last dose of study drug&#xD;
&#xD;
          -  Have a negative serum pregnancy test at screening and a negative predose urine&#xD;
             pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at&#xD;
             rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia,&#xD;
             family history of long QT Syndrome)&#xD;
&#xD;
          -  Participant is currently pregnant or planning to become pregnant or lactating (from&#xD;
             screening through at least 8 weeks after receiving the last dose of study drug)&#xD;
&#xD;
          -  Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus&#xD;
             antibody positive, or other clinically active liver disease, or tests positive for&#xD;
             HBsAg or hepatitis C virus antibody at screening.&#xD;
&#xD;
          -  Participant has a history of or present allergy to the oral contraceptive (OC) or&#xD;
             JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that,&#xD;
             in the opinion of the physician responsible, contraindicates their participation&#xD;
&#xD;
          -  Participant has a history of alcohol/drug abuse or dependence within 12 months of the&#xD;
             study: history of regular alcohol consumption averaging greater than (&gt;) 14&#xD;
             drinks/week for women within 6 months of screening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SGS Life Science Services</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>December 8, 2017</last_update_submitted>
  <last_update_submitted_qc>December 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levonorgestrel</mesh_term>
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Ethinyl estradiol, levonorgestrel drug combination</mesh_term>
    <mesh_term>Estradiol</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/NCT03249402
org study id: CR108351
secondary id: 2016-004725-16
secondary id: 42847922MDD1003
nct id: NCT03249402
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of
      JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination
      oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy
      female adult partcipants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax) in Cycle 1
time frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose
description: The Cmax is the maximum observed plasma concentration.
measure: Maximum Observed Plasma Concentration (Cmax) in Cycle 2
time frame: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose
description: The Cmax is the maximum observed plasma concentration.
measure: Trough Plasma Concentration (Ctrough) in Cycle 1
time frame: Cycle1: Predose (Day 21)
description: The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
measure: Trough Plasma Concentration (Ctrough) in Cycle 2
time frame: Cycle 2: Predose (Day 21)
description: The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1
time frame: Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose
description: The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2
time frame: Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose
description: The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
time frame: Up to 87 Days
description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
arm group label: Oral Contraceptive Tablet + JNJ-42847922
arm group type: Experimental
description: All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period).
intervention type: Drug
intervention name: Ethinyl Estradiol + Levonorgestrel
description: Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.
arm group label: Oral Contraceptive Tablet + JNJ-42847922
other name: Microgynon 30
intervention type: Drug
intervention name: JNJ-42847922
description: Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.
arm group label: Oral Contraceptive Tablet + JNJ-42847922
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Levonorgestrel
mesh term: Ethinyl Estradiol
mesh term: Ethinyl estradiol, levonorgestrel drug combination
mesh term: Estradiol