Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers
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ClinicalTrials.gov Identifier: NCT01480648 |
Recruitment Status
:
Completed
First Posted
: November 29, 2011
Last Update Posted
: November 1, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: BI 144807 Placebo Drug: BI 144807 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | February 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: BI144807
Subjects receive a single oral dose of BI144807solution
|
Drug: BI 144807
single dose (low to high dose)
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Placebo Comparator: Placebo
Subjects receive a single oral dose of placebo solution
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Drug: BI 144807 Placebo
Placebo that represents BI drug
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- All adverse events [ Time Frame: up to 14 days postdose ]
- Number of participants with clinically significant changes in vital signs [ Time Frame: up to 14 days postdose ]
- Number of participants with clinically significant changes in ECG [ Time Frame: up to 14 days postdose ]
- Number of participants with clinically significant changes in laboratory tests [ Time Frame: up to 14 days postdose ]
- Number of participants with clinically significant changes in physical examination [ Time Frame: up to 14 days postdose ]
- Number of participants tolerating BI 144807 [ Time Frame: up to 14 days postdose ]
- Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72h postdose ]
- tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72h postdose ]
- AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72h postdose ]
- AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 72h postdose ]
- t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72h postdose ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions

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): NCT01480648
Germany | |
1313.1.1 Boehringer Ingelheim Investigational Site | |
Biberach, Germany |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01480648 History of Changes |
Other Study ID Numbers: |
1313.1 2011-002560-24 ( EudraCT Number: EudraCT ) |
First Posted: | November 29, 2011 Key Record Dates |
Last Update Posted: | November 1, 2013 |
Last Verified: | October 2013 |