Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers

July 4, 2014 updated by: Boehringer Ingelheim

Bioavailability of BI 1356 After Single Oral Administration of 5 mg BI 1356 Given as Tablet Formulation TF IIb Relative to Tablet Formulation TF II and Tablet Formulation iFF in Healthy Male Volunteers (an Open Label, Randomised, Single-dose, Three-way Crossover Study)

Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF IIb

Study Overview

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, Blood Pressure (BP), Pulse Rate (PR), 12-lead Electrocardiogram (ECG), clinical laboratory tests

    • No findings deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  • Age ≥21 and Age ≤55 years
  • BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of study centre

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 1356 - Tablet TFII
Experimental: BI 1356 - Tablet iFF
Active Comparator: BI 1356 - Tablet TFIIb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Time Frame: predose, up to 24 hours
predose, up to 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
C24 (plasma concentration of the analyte 24 hours after dosing)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
λz (terminal rate constant in plasma)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
t1/2 (terminal half-life of the analyte in plasma)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
MRTpo (mean residence time of the analyte in the body after po administration)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time Frame: predose, up to 264 hours
predose, up to 264 hours
Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma
Time Frame: predose, up to 264 hours
predose, up to 264 hours
Changes in plasma glucose levels
Time Frame: predose, up to 264 hours
predose, up to 264 hours
Number of patients with adverse events
Time Frame: up to 18 days following last drug administration
up to 18 days following last drug administration
Number of patients with abnormal findings in physical examination
Time Frame: up to 18 days following last drug administration
up to 18 days following last drug administration
Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Time Frame: up to 18 days following last drug administration
up to 18 days following last drug administration
Number of patients with abnormal changes 12-lead ECG (electrocardiogram)
Time Frame: up to 18 days following last drug administration
up to 18 days following last drug administration
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 18 days following last drug administration
up to 18 days following last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time Frame: up to 18 days following last drug administration
up to 18 days following last drug administration

Collaborators and Investigators

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

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

February 1, 2007

Primary Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 4, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 4, 2014

Last Verified

July 1, 2014

More Information

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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