<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/NCT02183532</url>
  </required_header>
  <id_info>
    <org_study_id>1218.58</org_study_id>
    <nct_id>NCT02183532</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Single and Multiple Oral Doses of BI 1356 in Healthy Chinese Volunteers</brief_title>
  <official_title>Pharmacokinetics of Single and Multiple Oral Doses of 5 mg BI 1356 in Healthy Chinese Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of&#xD;
      5 mg in Chinese healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <primary_completion_date type="Actual">July 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>Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to day 19</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCτ (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)</measure>
    <time_frame>up to day 19</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (Time from dosing to maximum measured concentration) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)</measure>
    <time_frame>up to day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable analyte plasma concentration after single dose administration)</measure>
    <time_frame>up to day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-24 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after single dose administration)</measure>
    <time_frame>up to 24 h after single dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-72 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours after single dose administration)</measure>
    <time_frame>up to 72 h after single dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (Terminal rate constant in plasma) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (Terminal half-life of the analyte in plasma) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTpo (Mean residence time of the analyte in the body) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (Apparent clearance of the analyte in plasma after extravascular administration) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (Apparent volume of distribution during the terminal phase λz following extravascular administration) at different time points after single and multiple doses</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (Amount of analyte that is eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses</measure>
    <time_frame>up to 168 h after first dose and up to 24 h after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (Fraction of analyte eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses</measure>
    <time_frame>up to 168 h after first dose and up to 24 h after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) for multiple doses</measure>
    <time_frame>up to 144 h after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cavg,ss (Average concentration of the analyte in plasma at steady state)</measure>
    <time_frame>up to 144 h after last dose</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)</measure>
    <time_frame>up to 144 h after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLRt1-t2,ss (Renal clearance of the analyte at steady state from time point t1 to time point t2)</measure>
    <time_frame>up to 144 h after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cpre (Predose concentration of the analyte in plasma) at different time points</measure>
    <time_frame>up to 120 h after first of multiple doses</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTF (Peak-Trough Fluctuation)</measure>
    <time_frame>up to 120 h after first of multiple doses</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on Cmax</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RA,AUC (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on AUCτ</measure>
    <time_frame>up to day 19</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal findings in physical examination</measure>
    <time_frame>up to 25 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 25 days</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 25 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)</measure>
    <time_frame>up to 25 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 1356 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356 BS</intervention_name>
    <description>single dose</description>
    <arm_group_label>BI 1356 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1356 BS</intervention_name>
    <description>multiple doses</description>
    <arm_group_label>BI 1356 BS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male and female Chinese healthy volunteers who meet the criteria below:&#xD;
&#xD;
          -  Persons without clinically remarkable findings or clinically evident complications&#xD;
             based on their concurrent illness, past medical history, physical examination, vital&#xD;
             signs (blood pressure, pulse rate, and body temperature), 12-lead Electrocardiogram&#xD;
             (ECG), and laboratory test results&#xD;
&#xD;
          -  Age ≥18 and Age ≤45 years&#xD;
&#xD;
          -  Body weight ≥50 kg with BMI ≥19 and BMI ≤24 kg/m2 (Body Mass Index)&#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;
          -  Persons who deviate from the norm, and who show clinical findings (Blood pressure&#xD;
             (BP), Heart rate (HR), and ECG) on consultation&#xD;
&#xD;
          -  Persons with any clinically significant complications&#xD;
&#xD;
          -  Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,&#xD;
             immune, or hormonal disorders&#xD;
&#xD;
          -  Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or&#xD;
             neurological disorders&#xD;
&#xD;
          -  Persons with a history of significant orthostatic hypotension, syncopal attacks, or&#xD;
             blackouts&#xD;
&#xD;
          -  Persons with chronic infection or severe acute infection&#xD;
&#xD;
          -  Persons with a history of severe allergy/hypersensitivity (including allergies to&#xD;
             drugs or inactive ingredients)&#xD;
&#xD;
          -  Persons who will have received a drug with a long half-life (more than 24 hours)&#xD;
             within the month before treatment in this study, within a period 10 times longer than&#xD;
             the half-life of each drug, or during the study&#xD;
&#xD;
          -  Persons who will have received a drug that may theoretically affect the study results&#xD;
             based on the information obtained at the time of preparation of the protocol, within&#xD;
             the 10 days before treatment or during the study (e.g inhibitors or inducers of Pgp or&#xD;
             CYP 3A4)&#xD;
&#xD;
          -  Persons who will have participated in another trial of an investigational drug within&#xD;
             the 4 months before treatment or during the study&#xD;
&#xD;
          -  Smokers (who smoke more than 10 cigarettes, or 3 cigars, or 3 pipes per day)&#xD;
&#xD;
          -  Persons who cannot abstain from smoking throughout the study&#xD;
&#xD;
          -  Persons who undoubtedly abuse alcohol&#xD;
&#xD;
          -  Persons who abuse drugs&#xD;
&#xD;
          -  Persons who donate blood of 100 mL or more within the 4 weeks before treatment&#xD;
&#xD;
          -  Persons who perform rigorous exercise (within the week before treatment or during the&#xD;
             study)&#xD;
&#xD;
          -  Persons with any laboratory test result outside the reference range and for whom the&#xD;
             result is considered a clinically significant change&#xD;
&#xD;
          -  Persons who cannot obey the dieting rules of the study centre&#xD;
&#xD;
          -  Persons with any ECG value outside the reference range and who are of clinical&#xD;
             importance. Examples include, but are not limited to, QRS interval &gt;120 ms.&#xD;
&#xD;
          -  Pre-menopausal women (last menstruation &lt;1 year prior to the date of informed consent)&#xD;
             who:&#xD;
&#xD;
               -  are nursing or pregnant&#xD;
&#xD;
               -  or are of child-bearing potential and are not practicing an acceptable method of&#xD;
                  birth control, or do not plan to continue using this method throughout the study&#xD;
                  and do not agree to periodic pregnancy testing during their participation in the&#xD;
                  trial. Acceptable methods of birth control include transdermal patch, intra&#xD;
                  uterine devices/systems (IUDs/IUSs), oral, implantable or injectable&#xD;
                  contraceptives, sexual abstinence and vasectomised partner. No exception will be&#xD;
                  made.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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/1218/1218.58_U10-3113-02.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 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>
  </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/NCT02183532
org study id: 1218.58
nct id: NCT02183532
lead sponsor: 
Study to investigate the pharmacokinetics of BI 1356 after single and multiple oral doses of
      5 mg in Chinese healthy subjects
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state)
time frame: up to day 19
measure: AUCτ (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: up to day 19
measure: Cmax (Maximum measured concentration of the analyte in plasma) at different time points after single and multiple doses
time frame: up to day 19
measure: tmax (Time from dosing to maximum measured concentration) at different time points after single and multiple doses
time frame: up to day 19
measure: AUC0-infinity (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)
time frame: up to day 7
measure: AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of last quantifiable analyte plasma concentration after single dose administration)
time frame: up to day 7
measure: AUC0-24 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after single dose administration)
time frame: up to 24 h after single dose administration
measure: AUC0-72 (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours after single dose administration)
time frame: up to 72 h after single dose administration
measure: λz (Terminal rate constant in plasma) at different time points after single and multiple doses
time frame: up to day 19
measure: t1/2 (Terminal half-life of the analyte in plasma) at different time points after single and multiple doses
time frame: up to day 19
measure: MRTpo (Mean residence time of the analyte in the body) at different time points after single and multiple doses
time frame: up to day 19
measure: CL/F (Apparent clearance of the analyte in plasma after extravascular administration) at different time points after single and multiple doses
time frame: up to day 19
measure: Vz/F (Apparent volume of distribution during the terminal phase λz following extravascular administration) at different time points after single and multiple doses
time frame: up to day 19
measure: Aet1-t2 (Amount of analyte that is eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses
time frame: up to 168 h after first dose and up to 24 h after last dose
measure: fet1-t2 (Fraction of analyte eliminated in urine from time point t1 to time point t2) at different time points after single and multiple doses
time frame: up to 168 h after first dose and up to 24 h after last dose
measure: Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) for multiple doses
time frame: up to 144 h after last dose
measure: Cavg,ss (Average concentration of the analyte in plasma at steady state)
time frame: up to 144 h after last dose
measure: AUCτ,ss (Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
time frame: up to 144 h after last dose
measure: CLRt1-t2,ss (Renal clearance of the analyte at steady state from time point t1 to time point t2)
time frame: up to 144 h after last dose
measure: Cpre (Predose concentration of the analyte in plasma) at different time points
time frame: up to 120 h after first of multiple doses
measure: PTF (Peak-Trough Fluctuation)
time frame: up to 120 h after first of multiple doses
measure: RA,Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on Cmax
time frame: up to day 19
measure: RA,AUC (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) based on AUCτ
time frame: up to day 19
measure: Number of patients with adverse events
time frame: up to 28 days
measure: Number of patients with abnormal findings in physical examination
time frame: up to 25 days
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 25 days
measure: Number of patients with clinically significant changes in Vital signs (blood pressure [BP], pulse rate [PR])
time frame: up to 25 days
measure: Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
time frame: up to 25 days
arm group label: BI 1356 BS
arm group type: Experimental
intervention type: Drug
intervention name: BI 1356 BS
description: single dose
arm group label: BI 1356 BS
intervention type: Drug
intervention name: BI 1356 BS
description: multiple doses
arm group label: BI 1356 BS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.58_U10-3113-02.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Linagliptin