Bioavailability of BI 1356 BS and Metformin After Co-administration Compared to the Bioavailability of BI 1356 BS Alone and Metformin Alone in Healthy Male Volunteers

July 4, 2014 updated by: Boehringer Ingelheim

Bioavailability of Both BI 1356 BS and Metformin After Co-administration Compared to the Bioavailability of Multiple Oral Doses of BI 1356 BS 10 mg Daily Alone and Metformin 850 mg Three Times a Day Alone in Healthy Male Volunteers (an Open-label, Randomized, Crossover Study)

Investigate the bioavailability of BI 1356 BS and of metformin after concomitant multiple oral administration of 10 mg BI 1356 BS tablets and 3 x 850 mg metformin in comparison to BI 1356 BS and metformin given alone

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males 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 finding deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  • Age ≥ 21 and Age ≤ 50 years
  • BMI (Body Mass Index) ≥ 18.5 and ≤ 29.9 kg/m2
  • Ability to give 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 the 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 by the investigator
  • Intake of drugs with a long half-life (>24 hours) within one month or less than 10 half-lives of the respective drug prior to administration or during the conduct of this trial (review with clinical monitor if there is a question)
  • Use of drugs which might reasonably influence the results of the trial (based on knowledge at the time of protocol preparation) within 10 days prior to administration or during the conduct of this trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the conduct of this trial
  • Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
  • Inability to refrain from smoking during the conduct of this trial
  • Alcohol abuse (more than 60 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the conduct of this trial)
  • Excessive physical activities (within one week prior to administration or during the conduct of this trial)
  • Any laboratory value outside the normal reference range that is of clinical relevance
  • Inability to comply with the dietary regimen of the study center
  • No adequate contraception (condom use plus another form of contraception e.g., spermicide, oral contraceptive taken by female partner, sterilization) during the whole study period from the time of the first intake of study drug until one month after the last intake of drug

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Metformin
Drug: Metformin
Experimental: BI 1356 BS and metformin
Daily administration of BI 1356 BS alone (day 1 to day 6) followed by the combined treatment of BI 1356 BS with metformin (day 7 to day 9)
Drug: Metformin
Drug: BI 1356 BS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the concentration-time curve (AUC) of the analytes in plasma at different time points
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Maximum concentration (Cmax) of the analytes in plasma at different time points
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time from last dosing to maximum concentration of the analytes in plasma at steady state (tmax,ss)
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Minimum concentration of the analytes in plasma at steady state (Cmin,ss) over a uniform dosing interval τ
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Terminal rate constant of the analytes in plasma at steady state (λz,ss )
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Terminal half-life of the analytes in plasma at steady state (t1/2,ss )
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Mean residence time of the analytes in the body at steady state after oral administration (MRTpo,ss)
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Apparent clearance of the analytes in the plasma at steady state (CL/F,ss) following extravascular multiple dose administration
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Apparent volume of distribution during the terminal phase λz at steady state (Vz/F,ss) following extravascular administration
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Measurements of dipeptidylpeptidase 4 (DPP-IV) activity
Time Frame: up to 240 hours after start of treatment
up to 240 hours after start of treatment
Number of patients with adverse events
Time Frame: up to 60 days
up to 60 days
Number of patients with clinically abnormal changes in laboratory values
Time Frame: Baseline, up to 14 days after last drug administration
Baseline, up to 14 days after last drug administration
Number of patients with clinically relevant changes in vital signs
Time Frame: Baseline, up to 14 days after last drug administration
Baseline, up to 14 days after last drug administration
feτ,ss (fraction of the dose excreted unchanged in urine at steady state)
Time Frame: 0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9
0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9
CLR,ss (renal clearance of the analyte in plasma at steady state)
Time Frame: 0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9
0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1218.4

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