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First in Man Trial of BI 113608

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01540825
First received: February 13, 2012
Last updated: November 23, 2016
Last verified: November 2016
February 13, 2012
November 23, 2016
February 2012
May 2012   (Final data collection date for primary outcome measure)
  • Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test [ Time Frame: From administration of study drug until end-of-study visit, up to 10 days ]
    Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test
  • Percentage of Participants With Drug-related Adverse Events [ Time Frame: From administration of study drug until end-of-study visit, up to 10 days ]
    Percentage of participants with drug-related adverse events
  • Assessment of Tolerability by the Investigator [ Time Frame: End of study visit, up to day 10 ]
    Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.
  • Number of participants with changes from baseline in physical examination (as judged as adverse events) [ Time Frame: Up to 13 weeks ]
  • Orthostasis test [ Time Frame: Up to 13 weeks ]
  • Number of participants with changes from baseline in electrocardiogram (ECG) results [ Time Frame: Up to 13 weeks ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: Up to 13 weeks ]
  • Lung function (Forced Expiratory Volume in 1 second (FEV1) and airway resistance (Raw) as measured by body plethysmography) [ Time Frame: Up to 13 weeks ]
  • Carbon monoxyde diffusing capacity (DLCO) [ Time Frame: Up to 13 weeks ]
  • Oxygen saturation (SpO2) as measured by non-invasive pulse oxymetry [ Time Frame: Up to 13 weeks ]
  • Haemoccult testing [ Time Frame: Up to 13 weeks ]
  • Number of participants with adverse events [ Time Frame: Up to 13 weeks ]
  • Assessment of tolerability by investigator (tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad) [ Time Frame: Up to 13 weeks ]
Complete list of historical versions of study NCT01540825 on ClinicalTrials.gov Archive Site
  • Cmax [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]

    Maximum measured concentration of the analyte in plasma (Cmax).

    The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK.

  • Tmax [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
  • AUC0-tz [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    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 (AUC0-tz)
  • AUC0-infinity [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
  • t1/2 [ Time Frame: Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration ]
    Terminal half-life of the analyte in plasma (t1/2)
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 13 weeks ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: Up to 13 weeks ]
  • 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: Up to 13 weeks ]
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.) [ Time Frame: Up to 13 weeks ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Up to 13 weeks ]
Not Provided
Not Provided
 
First in Man Trial of BI 113608
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
  • Drug: BI 113608
    Low dose powder for oral solution
  • Drug: BI 113608
    High dose powder for oral solution
  • Drug: BI 113608
    Medium dose powder for oral solution
  • Drug: Placebo
    Powder for oral solution
  • Experimental: BI 113608 high dose 1
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 low dose 1
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 low dose 2
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 low dose 4
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 low dose 5
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 medium dose 1
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 medium dose 2
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 medium dose 3
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 high dose 2
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 high dose 3
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Placebo Comparator: Placebo
    Powder for oral solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01540825
1314.1
2011-005034-19 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2016

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