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

Boehringer Ingelheim

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: BI 691751 after high fat breakfast; Drug: BI 691751 fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT02175238

1334.28

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

BI 691751 after high fat breakfast

Experimental group

Description:

single dose BI 691751 after a standardised high fat breakfast

Treatment:

Drug: BI 691751 after high fat breakfast

BI 691751 fasted

Active Comparator group

Description:

single dose BI 691751 in fasted state

Treatment:

Drug: BI 691751 fasted