Clinical Drug Trial in Healthy Male Subjects to Determine and Compare the Blood Concentrations of BI 144807 Following Administration as Oral Solution and Tablet Under Fasted and Fed Conditions

September 4, 2013 updated by: Boehringer Ingelheim

An Open-label, Single Dose, Randomised, Crossover Trial in Healthy Male Subjects to Investigate the Relative Bioavailability of Tablet and Oral Solution of Two Doses of BI 144807 and Relative Bioavailability of BI 144807 When Administered as Tablet Under Fed and Fasted Conditions

The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

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
        • 1313.9.1 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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

- Healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy condition

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: BI 144807 PfoS Treatment A
intermediate dose of BI 144807
Drug: BI 144807 intermediate dose
tablet
Drug: BI 144807 intermediate dose
oral solution
Experimental: BI 144807 PfoS Treatment C
high dose of BI 144807
Drug: BI 144807 high dose
oral solution
Drug: BI 144807 high dose
tablet
Experimental: BI 144807 Tab Treatment B
intermediate dose of BI 144807
Drug: BI 144807 intermediate dose
tablet
Drug: BI 144807 intermediate dose
oral solution
Experimental: BI 144807 Tab Treatment D
high dose of BI 144807
Drug: BI 144807 high dose
oral solution
Drug: BI 144807 high dose
tablet
Experimental: BI 144807 Tab Treatment E
intermediate dose of BI 144807, fasted
Drug: BI 144807 intermediate dose
tablet
Drug: BI 144807 intermediate dose
oral solution
Experimental: BI 144807 Tab Treatment F
intermediate dose of BI 144807, fed
Drug: BI 144807 intermediate dose
tablet
Drug: BI 144807 intermediate dose
oral solution
Experimental: BI 144807 Tab Treatment G
intermediate dose of BI 144807, fasted
Drug: BI 144807 intermediate dose
tablet
Drug: BI 144807 intermediate dose
oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame: 48 hours
48 hours
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time Frame: 48 hours
48 hours

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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

July 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 9, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 1313.9
  • 2013-000258-23 (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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