Safety Tolerability and Pharmacokinetic of BI 411034

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01581684
First received: April 19, 2012
Last updated: March 13, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

  • Amount of Analyte Eliminated in Urine From 0 to 4 (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 ] [ Designated as safety issue: No ]
    Amount of analyte eliminated in urine from the time point 0 to time point 4


Enrollment: 62
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 411034 low dose
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Experimental: BI 411034 low dose
Solution for oral administration
Drug: BI 411034
Low dose solution for oral administration
Experimental: BI 411034 medium dose
Solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 medium dose
Solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 medium dose
Solution for oral administration
Drug: BI 411034
Medium dose solution for oral administration
Experimental: BI 411034 high dose
Solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose
Solution for oral administration
Drug: BI 411034
High dose solution for oral administration
Experimental: BI 411034 high dose
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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01581684     History of Changes
Other Study ID Numbers: 1308.1, 2011-004840-23
Study First Received: April 19, 2012
Results First Received: March 13, 2014
Last Updated: March 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on August 01, 2014