Status:

COMPLETED

Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Healthy

Eligibility:

MALE

20-45 years

Phase:

PHASE1

Brief Summary

Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Healthy male Chinese and Japanese volunteers
  • Age between 20 and 45 years
  • BMI between 18.5 and 25 kg/m2 (Body Mass Index)
  • Known genotype as specified in the study protocol
  • Subjects must be able to understand and comply with study requirements
  • Exclusion criteria:
  • 1\. Any deviation from healthy condition

Exclusion

    Key Trial Info

    Start Date :

    April 22 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 18 2013

    Estimated Enrollment :

    65 Patients enrolled

    Trial Details

    Trial ID

    NCT01841112

    Start Date

    April 22 2013

    End Date

    July 18 2013

    Last Update

    June 25 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    1289.4.8201 Boehringer Ingelheim Investigational Site

    Seoul, South Korea