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

NCT02175238 | Withdrawn Phase 1

• 1 other identifier: 1334.28
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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)

  up to 480 hours

• Maximum measured concentration of the analyte in plasma and whole blood (Cmax)

  up to 480 hours

Secondary Outcomes (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)

  up to 480 hours

Study Arms (2)

BI 691751 after high fat breakfast

EXPERIMENTAL

single dose BI 691751 after a standardised high fat breakfast

Drug: BI 691751 after high fat breakfast

BI 691751 fasted

ACTIVE COMPARATOR

single dose BI 691751 in fasted state

Drug: BI 691751 fasted

Interventions

BI 691751 fasted DRUG

single dose BI 691751 in fasted state

BI 691751 fasted

BI 691751 after high fat breakfast DRUG

single dose BI 691751 after a standardised high fat breakfast

BI 691751 after high fat breakfast

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1334.28.01001 Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)