<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/NCT02183584</url>
  </required_header>
  <id_info>
    <org_study_id>1218.67</org_study_id>
    <nct_id>NCT02183584</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effect of Multiple Doses of Rifampicin on the Multiple-dose Pharmacokinetics of Linagliptin in Healthy Volunteers</brief_title>
  <official_title>An Open Label, Two-period, Fixed Sequence, Phase 1 Trial to Evaluate the Effect of Multiple Doses of Rifampicin on the Multiple-dose Pharmacokinetics of Linagliptin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Investigation of the bioavailability of linagliptin after concomitant multiple oral&#xD;
      administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison&#xD;
      to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <primary_completion_date type="Actual">October 2009</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>Area under the steady state concentration-time curve of linagliptin in plasma (AUCτ,ss)</measure>
    <time_frame>up to 19 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured steady state concentration of linagliptin in plasma (Cmax,ss)</measure>
    <time_frame>up to 19 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dipeptidyl-peptidase 4 (DPP-4) inhibition</measure>
    <time_frame>up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790</measure>
    <time_frame>up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790</measure>
    <time_frame>up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of urinary concentrations of 6β-hydroxycortisol to cortisol</measure>
    <time_frame>screening, days 1 and 6 of treatment A, days 4, 6, 8 and 12 of treatment B always in the morning before drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2,ss ( amount of analyte that is eliminated in urine from the time point t1 to time point t2 under steady state conditions) of linagliptin</measure>
    <time_frame>up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2,ss ( fraction of administered drug excreted unchanged in urine at steady state over the respective time interval, where t1 and t2 define beginning and end times of the time interval) of linagliptin</measure>
    <time_frame>up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 42 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of global tolerability by investigator on a 4-point scale</measure>
    <time_frame>up to 21 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal findings in physical examination</measure>
    <time_frame>up to 21 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 21 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in Vital signs (Blood Pressure (BP), Pulse Rate (PR))</measure>
    <time_frame>up to 21 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram)</measure>
    <time_frame>up to 21 days after last drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Rifampicin and Linagliptin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampicin</intervention_name>
    <arm_group_label>Rifampicin and Linagliptin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Linagliptin</intervention_name>
    <arm_group_label>Rifampicin and Linagliptin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females according to the following criteria: Based upon a complete&#xD;
             medical history, including the physical examination, vital signs (Blood Pressure (BP),&#xD;
             Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests&#xD;
&#xD;
          -  Age 18 to 50 years (incl.)&#xD;
&#xD;
          -  BMI 18.5 to 29.9 kg/m2 (incl.)&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with Good clinical practice (GCP) and the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any finding of the medical examination (including BP, PR and ECG) deviating from&#xD;
             normal and of clinical relevance&#xD;
&#xD;
          -  Any evidence of a clinically relevant concomitant disease&#xD;
&#xD;
          -  Gastrointestinal, hepatic (incl. porphyrias), renal, respiratory, cardiovascular,&#xD;
             metabolic, immunological or hormonal disorders&#xD;
&#xD;
          -  Surgery of the gastrointestinal tract (except appendectomy)&#xD;
&#xD;
          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or&#xD;
             neurological disorders&#xD;
&#xD;
          -  History of relevant orthostatic hypotension, fainting spells or blackouts.&#xD;
&#xD;
          -  Chronic or relevant acute infections&#xD;
&#xD;
          -  History of relevant allergy or hypersensitivity (including allergy to drug or its&#xD;
             excipients)&#xD;
&#xD;
          -  Intake of drugs with a long half-life (more than 24 hours) within at least one month&#xD;
             or less than 10 half-lives of the respective drug prior to administration or during&#xD;
             the trial&#xD;
&#xD;
          -  Participation in another trial with an investigational drug within two months prior to&#xD;
             administration or during the trial&#xD;
&#xD;
          -  Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)&#xD;
&#xD;
          -  Inability to refrain from smoking on trial days&#xD;
&#xD;
          -  Alcohol abuse (more than 30 g/day if male, more than 20 g/day if female)&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Blood donation (more than 100 mL within four weeks prior to administration or during&#xD;
             the trial)&#xD;
&#xD;
          -  Excessive physical activities (within one week prior to administration or during the&#xD;
             trial)&#xD;
&#xD;
          -  Any laboratory value outside the reference range that is of clinical relevance&#xD;
&#xD;
          -  Inability to comply with dietary regimen of trial site&#xD;
&#xD;
          -  Thrombocytopenia or increased liver function tests (i.e. Alanine transaminase (ALT),&#xD;
             Aspartate transaminase (AST), bilirubin, Alkaline phosphatase (AP), Gamma-glutamyl&#xD;
             transferase (GGT)) at screening&#xD;
&#xD;
          -  prior rifampicin exposure&#xD;
&#xD;
        For female subjects:&#xD;
&#xD;
          -  Positive pregnancy test, pregnancy or planning to become pregnant during the study or&#xD;
             within 2 months after study completion&#xD;
&#xD;
          -  No adequate contraception during the study and until 1 month after study completion,&#xD;
             i.e. not any of the following: IUD (intrauterine device), sexual abstinence for at&#xD;
             least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1&#xD;
             year prior to enrolment), or surgical sterilisation (including hysterectomy). Females,&#xD;
             who do not have a vasectomised partner, are not sexually abstinent or surgically&#xD;
             sterile have to use an additional barrier method (e.g. condom, diaphragm with&#xD;
             spermicide)&#xD;
&#xD;
          -  Lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.67_U10-1328-01.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</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>Linagliptin</mesh_term>
    <mesh_term>Rifampin</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/NCT02183584
org study id: 1218.67
nct id: NCT02183584
lead sponsor: 
Investigation of the bioavailability of linagliptin after concomitant multiple oral
      administration of 5 mg linagliptin tablets and 600 mg rifampicin (Treatment A) in comparison
      to multiple oral administration of 5 mg linagliptin tablets given alone (Treatment B)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the steady state concentration-time curve of linagliptin in plasma (AUCτ,ss)
time frame: up to 19 days
measure: Maximum measured steady state concentration of linagliptin in plasma (Cmax,ss)
time frame: up to 19 days
measure: Dipeptidyl-peptidase 4 (DPP-4) inhibition
time frame: up to 19 days
measure: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790
time frame: up to 19 days
measure: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of CD 1790
time frame: up to 19 days
measure: Ratio of urinary concentrations of 6β-hydroxycortisol to cortisol
time frame: screening, days 1 and 6 of treatment A, days 4, 6, 8 and 12 of treatment B always in the morning before drug administration
measure: Aet1-t2,ss ( amount of analyte that is eliminated in urine from the time point t1 to time point t2 under steady state conditions) of linagliptin
time frame: up to 19 days
measure: fet1-t2,ss ( fraction of administered drug excreted unchanged in urine at steady state over the respective time interval, where t1 and t2 define beginning and end times of the time interval) of linagliptin
time frame: up to 19 days
measure: Number of patients with adverse events
time frame: up to 42 days
measure: Assessment of global tolerability by investigator on a 4-point scale
time frame: up to 21 days after last drug administration
measure: Number of patients with abnormal findings in physical examination
time frame: up to 21 days after last drug administration
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 21 days after last drug administration
measure: Number of patients with clinically significant changes in Vital signs (Blood Pressure (BP), Pulse Rate (PR))
time frame: up to 21 days after last drug administration
measure: Number of patients with clinically significant changes in 12-lead ECG (electrocardiogram)
time frame: up to 21 days after last drug administration
arm group label: Rifampicin and Linagliptin
arm group type: Experimental
intervention type: Drug
intervention name: Rifampicin
arm group label: Rifampicin and Linagliptin
intervention type: Drug
intervention name: Linagliptin
arm group label: Rifampicin and Linagliptin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.67_U10-1328-01.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Linagliptin
mesh term: Rifampin