- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183363
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1218.25
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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