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Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02175238
Recruitment Status : Withdrawn
First Posted : June 26, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 691751 fasted Drug: BI 691751 after high fat breakfast Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
Study Start Date : July 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: BI 691751 after high fat breakfast
single dose BI 691751 after a standardised high fat breakfast
Drug: BI 691751 after high fat breakfast
single dose BI 691751 after a standardised high fat breakfast

Active Comparator: BI 691751 fasted
single dose BI 691751 in fasted state
Drug: BI 691751 fasted
single dose BI 691751 in fasted state




Primary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: up to 480 hours ]
  2. Maximum measured concentration of the analyte in plasma and whole blood (Cmax) [ Time Frame: up to 480 hours ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf) [ Time Frame: up to 480 hours ]


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 males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogramm (ECG), and clinical laboratory tests
  2. Age 18 to 50 years (incl.)
  3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

Exclusion criteria:

  1. Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and 12-lead Electrocardiogramm (ECG)) deviating from normal and judged clinically relevant by the investigator
  2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
  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 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 study drug
  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): NCT02175238


Locations
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United States, Wisconsin
1334.28.01001 Boehringer Ingelheim Investigational Site
Madison, Wisconsin, United States
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: NCT02175238    
Other Study ID Numbers: 1334.28
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014