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

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ClinicalTrials.gov Identifier: NCT01841112
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 409306 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Oral Doses of BI 409306 (Tablet) in Healthy Chinese and Japanese Male Volunteers and Multiple Oral Doses of BI 409306 (Tablet) in Healthy Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Placebo Comparator: Placebo (Multiple dose part)
Placebo tablet
Drug: placebo
placebo tablet

Experimental: Dose 2, EM, single dose
Extensive Metaboliser (EM), single dose part, medium dose
Drug: BI 409306
tablet

Experimental: Dose 3, EM, single dose
Extensive Metaboliser (EM), single dose part, high dose
Drug: BI 409306
tablet

Experimental: Dose 3, PM, single dose
Poor Metaboliser (PM), single dose part, high dose
Drug: BI 409306
tablet

Experimental: Dose 3, PM, multiple dose
Poor Metaboliser (PM), multiple dose part, high dose
Drug: BI 409306
tablet

Placebo Comparator: Placebo (Single dose part)
Placebo tablet
Drug: placebo
placebo tablet

Experimental: Dose 1, EM, single dose
Extensive Metaboliser (EM), single dose part, low dose
Drug: BI 409306
tablet




Primary Outcome Measures :
  1. The number (%) of subjects with drug related Adverse Events [ Time Frame: up to 13 days ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 13 days ]
  2. 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 days ]
  3. AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point ) [ Time Frame: up to 13 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy male Chinese and Japanese volunteers
  2. Age between 20 and 45 years
  3. BMI between 18.5 and 25 kg/m2 (Body Mass Index)
  4. Known genotype as specified in the study protocol
  5. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. Any deviation from healthy condition


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): NCT01841112


Locations
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Korea, Republic of
1289.4.8201 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01841112     History of Changes
Other Study ID Numbers: 1289.4
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015