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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 691751 after high fat breakfast

single dose BI 691751 after a standardised high fat breakfast

Group Type EXPERIMENTAL

BI 691751 after high fat breakfast

Intervention Type DRUG

single dose BI 691751 after a standardised high fat breakfast

BI 691751 fasted

single dose BI 691751 in fasted state

Group Type ACTIVE_COMPARATOR

BI 691751 fasted

Intervention Type DRUG

single dose BI 691751 in fasted state

Interventions

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BI 691751 fasted

single dose BI 691751 in fasted state

Intervention Type DRUG

BI 691751 after high fat breakfast

single dose BI 691751 after a standardised high fat breakfast

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes