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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
  Purpose

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)


Condition Intervention Phase
Healthy Drug: BI 411034 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 62
Actual Study Start Date: April 1, 2012
Study Completion Date: August 1, 2012
Primary Completion Date: August 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 411034 low dose - group 1
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Experimental: BI 411034 low dose - group 2
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Experimental: BI 411034 medium dose - group 3
Solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 medium dose - group 4
Solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 medium dose - group 5
Solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 high dose - group 6
Solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose - group 7
Solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose - group 8
Solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Placebo Comparator: Placebo
Solution for oral administration
Drug: Placebo
Solution for oral administration

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581684


Locations
Germany
1308.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01581684     History of Changes
Other Study ID Numbers: 1308.1
2011-004840-23 ( EudraCT Number: EudraCT )
First Submitted: April 19, 2012
First Posted: April 20, 2012
Results First Submitted: March 13, 2014
Results First Posted: April 17, 2014
Last Update Posted: August 15, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pharmaceutical Solutions