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CompletedNCT02183298Updated Jul 8, 2014

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

A Phase 1 interventional study of BI 1356 BS - intravenous and BI 1356 BS - Tablet in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1356 as formulation for intravenous administration

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
  • Age ≥18 and Age ≤50 years
  • BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of study centre
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for Torsade de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Exclusion criteria specific for this study:

  • Veins unsuitable for infusion
  • PR interval >220 ms or QRS interval >120 ms
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
36 participants (actual)

Study arms

  • Experimental
    BI 1356 BS - single rising dose

    Drug: BI 1356 BS - intravenous · Drug: BI 1356 BS - Tablet

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Number of patients with abnormal findings in physical examination

    Time frame: Screening, up to 14 days following drug administration

  2. Number of patients with clinically changes in vital signs (blood pressure [BP], pulse rate [PR])

    Time frame: Screening, up to 14 days following drug administration

  3. Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)

    Time frame: Screening, up to 14 days following drug administration

  4. Number of patients with abnormal changes in laboratory parameters

    Time frame: Screening, up to 14 days following drug administration

  5. Number of patients with adverse events

    Time frame: up to 35 days

  6. Assessment of tolerability by investigator on a 4-point scale

    Time frame: up to 14 days following drug administration

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: predose, up to 192 h following drug administration

  2. tmax (time from dosing to maximum measured concentration)

    Time frame: predose, up to 192 h following drug administration

  3. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: predose, up to 192 h following drug administration

  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

    Time frame: predose, up to 192 h following drug administration

  5. 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 data point)

    Time frame: predose, up to 192 h following drug administration

  6. λz (terminal rate constant in plasma)

    Time frame: predose, up to 192 h following drug administration

  7. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: predose, up to 192 h following drug administration

  8. MRT/ MRTpo (mean residence time of the analyte in the body after iv/oral administration)

    Time frame: predose, up to 192 h following drug administration

  9. CL/ CL/F (total clearance of the analyte in plasma after iv/oral administration)

    Time frame: predose, up to 192 h following drug administration

  10. Vz/ Vz/F (apparent volume of distribution during the terminal phase λz following an iv/oral dose)

    Time frame: predose, up to 192 h following drug administration

  11. Vss (apparent volume of distribution at steady state following intravascular administration)

    Time frame: predose, up to 192 h following drug administration

  12. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)

    Time frame: predose, up to 120 h following drug administration

  13. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)

    Time frame: predose, up to 120 h following drug administration

  14. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)

    Time frame: predose, up to 120 h following drug administration

  15. Changes of Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma

    Time frame: up to 192 h following drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02183298
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 8, 2014
Start date
May 2006
Primary completion
Jul 2006
Last update
Jul 8, 2014
View the source record on ClinicalTrials.gov ↗

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