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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02175238
• Other study ID #: 1334.28
• Status: Withdrawn
• Phase: Phase 1
• First received: June 25, 2014
• Last updated: July 23, 2014
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 691751 fasted
single dose BI 691751 in fasted state
• BI 691751 after high fat breakfast
single dose BI 691751 after a standardised high fat breakfast

Locations

Country	Name	City	State
United States	1334.28.01001 Boehringer Ingelheim Investigational Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximum measured concentration of the analyte in plasma and whole blood (Cmax)		up to 480 hours	No
Secondary	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	No