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: December 5, 2012
Last verified: December 2012

February 13, 2012
December 5, 2012
February 2012
May 2012   (final data collection date for primary outcome measure)
  • Number of participants with changes from baseline in physical examination (as judged as adverse events) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Orthostasis test [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with changes from baseline in electrocardiogram (ECG) results [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Lung function (Forced Expiratory Volume in 1 second (FEV1) and airway resistance (Raw) as measured by body plethysmography) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Carbon monoxyde diffusing capacity (DLCO) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Oxygen saturation (SpO2) as measured by non-invasive pulse oxymetry [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Haemoccult testing [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540825 on ClinicalTrials.gov Archive Site
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety Study
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
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 low dose
    Powder for oral solution
    Intervention: Drug: BI 113608
  • Experimental: BI 113608 medium dose
    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

Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01540825
1314.1, 2011-005034-19
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2012

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