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Safety Tolerability and Pharmacokinetic of BI 411034

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581684
First Posted: April 20, 2012
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
April 19, 2012
April 20, 2012
March 13, 2014
April 17, 2014
August 15, 2017
April 1, 2012
August 1, 2012   (Final data collection date for primary outcome measure)
  • Number of Participants With Drug Related AEs [ Time Frame: From drug administration until end of trial examination, up to 13 days ]
    Number of participants with drug related adverse events (AEs)
  • Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests [ Time Frame: From drug administration until end of trial examination, up to 13 days ]
    Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
  • Number of participants with clinically relevant findings in physical examination [ Time Frame: Up to 16 weeks ]
  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: Up to 16 weeks ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: Up to 16 weeks ]
  • Number of participants with adverse events [ Time Frame: Up to 16 weeks ]
Complete list of historical versions of study NCT01581684 on ClinicalTrials.gov Archive Site
  • Maximum Measured Concentration (Cmax ) [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]
    Maximum measured concentration of the analyte (BI 411034) in plasma
  • Time to Maximum Measured Concentration (Tmax) [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]
    Time from dosing to maximum measured concentration
  • Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity) [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]
    Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
  • Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4) [ Time Frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration ]
    Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 16 weeks ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: Up to 16 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 16 weeks ]
  • Ae0-t1 (amount of analyte eliminated in urine from the time point 0 to time point t1) [ Time Frame: Up to 16 weeks ]
Not Provided
Not Provided
 
Safety Tolerability and Pharmacokinetic of BI 411034
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)

The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Healthy
  • Drug: BI 411034
    Low dose solution for oral administration
  • Drug: Placebo
    Solution for oral administration
  • Drug: BI 411034
    Medium dose solution for oral administration
  • Drug: BI 411034
    High dose solution for oral administration
  • Experimental: BI 411034 low dose - group 1
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 low dose - group 2
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 medium dose - group 3
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 medium dose - group 4
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 medium dose - group 5
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 high dose - group 6
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 high dose - group 7
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Experimental: BI 411034 high dose - group 8
    Solution for oral administration
    Intervention: Drug: BI 411034
  • Placebo Comparator: Placebo
    Solution for oral administration
    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
62
August 1, 2012
August 1, 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
 
 
NCT01581684
1308.1
2011-004840-23 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2017

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