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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02183311
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 4, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE June 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2014)
  • Number of patients with abnormal findings in physical examination [ Time Frame: Screening, up to 28 days ]
  • Number of patients with clinically significant changes in Vital signs (blood pressure [BP], pulse rate [PR]) [ Time Frame: Screening, up to 28 days ]
  • Number of patients with abnormal findings in 12-lead electrocardiogram (ECG) [ Time Frame: Screening, up to 28 days ]
  • Number of patients with abnormal changes in laboratory parameters [ Time Frame: Screening, up to 28 days ]
  • Number of patients with adverse events [ Time Frame: up to 49 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2014)
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • %AUCtz-∞ (the percentage of the AUCtz-∞ that is obtained by extrapolation) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable analyte plasma concentration) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from the time point t1 to the time point t2) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • MRTpo (mean residence time of the analyte in the body) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following extravascular administration) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to the time point t2) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to the time point t2) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • CLR,0-24,1 (renal clearance of the analyte from 0 until 24 hours after administration of the first dose) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • Cavg (average concentration of the analyte in plasma at steady state) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • Cpre (predose concentration of the analyte in plasma) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • RA,Cmax based on Cmax [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • RA,AUC based on AUCτ [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • Emin (minimum Dipeptidyl-Peptidase IV (DPP-IV) activity [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • tmin (time to reach minimum DPP-IV activity) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
  • E24 (DPP-IV activity 24 hours after administration of single dose administration and the first dose of multiple dose administration) [ Time Frame: up to 192 h (single dose), up to 456 h (multiple dose) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male Volunteers
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses (1 to 10 mg) and Multiple Rising Oral Doses (2.5 to 10 mg Once Daily for 12 Days) of BI 1356 BS in Healthy Male Volunteers (a Randomised, Double-blind, Placebo Controlled Within Dose Groups Clinical Trial)
Brief Summary Study to examine the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS administered to healthy male volunteers at single rising oral doses (1 mg, 2.5 mg, 5 mg, and 10 mg) and at multiple rising oral doses (2.5 mg, 5 mg, and 10 mg once daily for 12 days)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BI 1356 BS - single rising dose
  • Drug: BI 1356 BS - multiple rising dose
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BI 1356 BS - single rising dose
    Intervention: Drug: BI 1356 BS - single rising dose
  • Experimental: BI 1356 BS - multiple rising dose
    Intervention: Drug: BI 1356 BS - multiple rising dose
  • Active Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2014)
56
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects will be healthy male volunteers who meet the criteria below: Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure (BP), pulse rate (PR), and body temperature), 12-lead Electrocardiogram (ECG), and laboratory test results
  • Persons who are 20 or older and 35 or younger
  • Persons with a BMI 17.6 kg/m2 or more and 29.9 kg/m2 or less
  • Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with GCP (Good Clinical Practice, MHW Ordinance No. 28 dated March 27, 1997)

Exclusion Criteria:

  • Persons who deviate from the norm and who show clinical findings (BP, PR, and ECG) on consultation
  • Persons with any clinically relevant complications
  • Persons with gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immune, or hormonal disorders
  • Persons with central nervous system disorders (e.g., epilepsy), mental disorders, or neurological disorders
  • Persons with a history of significant orthostatic hypotension, syncopal attacks, or blackouts
  • Persons with chronic infection or severe acute infection
  • Persons with a history of severe allergy/hypersensitivity including allergies to drugs and inactive ingredients
  • Persons who will have received a drug with a long half-life (more than 24 hours) within the month before treatment in this trial, within a period 10 times longer than the half-life of each drug, or during the study
  • Persons who will have received a drug that may theoretically affect the study results based on the information obtained at the time of preparation of the protocol within the 10 days before treatment or during the study
  • Persons who will have participated in another trial of an investigational drug within the 4 months before treatment or during the study
  • Smokers (who smoke more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Persons who cannot abstain from smoking throughout the study
  • Persons who undoubtedly abuse alcohol
  • Persons who abuse drugs
  • Persons who donate blood of 100 mL or more within the 4 weeks before treatment
  • Persons who perform rigorous exercise (within the week before treatment or during the study)
  • Persons with any laboratory test result outside the reference range and for whom the result is considered a clinically relevant change
  • Persons who cannot obey the dieting rules of the trial site
  • Persons with any ECG value outside the reference range and who are of clinical importance. Examples include, but are not limited to, QRS interval>120 ms
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183311
Other Study ID Numbers  ICMJE 1218.11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP