Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers

January 26, 2016 updated by: Boehringer Ingelheim

Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Bioavailability of the Tablet Formulation (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Subjects)

To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Biberach, Germany
        • 1307.3.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

  1. Healthy male subjects
  2. Age of 18 to 50 years
  3. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

  1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  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 as 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 trial medication (except appendectomy and simple hernia repair)
  7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
single dose of BI 187004 in fasted state
Drug: BI 187004
single dose BI 187004 given as tablet in fed state
Drug: BI 187004
single dose BI 187004 given as tablet in fasted state
Drug: BI 187004
single dose BI 187004 given as oral solution
Experimental: Treatment B
single dose of BI 187004
Drug: BI 187004
single dose BI 187004 given as tablet in fed state
Drug: BI 187004
single dose BI 187004 given as tablet in fasted state
Drug: BI 187004
single dose BI 187004 given as oral solution
Experimental: Treatment C
single dose of BI 187004 in fed state
Drug: BI 187004
single dose BI 187004 given as tablet in fed state
Drug: BI 187004
single dose BI 187004 given as tablet in fasted state
Drug: BI 187004
single dose BI 187004 given as oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004
Time Frame: up to 17 days postdose
up to 17 days postdose
Cmax (maximum measured concentration of the analyte in plasma) of BI 187004
Time Frame: up to 17 days postdose
up to 17 days postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 17 days postdose
up to 17 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1307.3
  • 2013-004627-37 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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