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Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02161432
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 187004 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Bioavailability of the Tablet Formulation (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Subjects)
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Treatment A
single dose of BI 187004 in fasted state
Drug: BI 187004
single dose BI 187004 given as tablet in fasted state

Experimental: Treatment B
single dose of BI 187004
Drug: BI 187004
single dose BI 187004 given as oral solution

Experimental: Treatment C
single dose of BI 187004 in fed state
Drug: BI 187004
single dose BI 187004 given as tablet in fed state




Primary Outcome Measures :
  1. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004 [ Time Frame: up to 17 days postdose ]
  2. Cmax (maximum measured concentration of the analyte in plasma) of BI 187004 [ Time Frame: up to 17 days postdose ]

Secondary Outcome Measures :
  1. 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 17 days postdose ]


Information from the National Library of Medicine

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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
  2. Age of 18 to 50 years
  3. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

  1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
  7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

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): NCT02161432


Locations
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Germany
1307.3.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02161432    
Other Study ID Numbers: 1307.3
2013-004627-37 ( EudraCT Number: EudraCT )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016