Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
Withdrawn before enrolling · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02175238
- Run by
- Boehringer Ingelheim
- People needed
- 0
- Starts
- 2014-07-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2014-07-24
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
- Age 18 to 50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
You may not qualify if…
- 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
- Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Where it is running
- 1334.28.01001 Boehringer Ingelheim Investigational Site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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