HealthyPhase 1NCT02183363
Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers
A Phase 1 study testing BI 1356 - Tablet TFII, BI 1356 - Tablet iFF and BI 1356 - Tablet TFIIb in people with Healthy, run by Boehringer Ingelheim.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1356 - Tablet TFII, BI 1356 - Tablet iFF and BI 1356 - Tablet TFIIb
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to May 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- BI 1356 - Tablet TFII, BI 1356 - Tablet iFF, BI 1356 - Tablet TFIIb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1356 - Tablet TFIIDrug
BI 1356 - Tablet iFFDrug
BI 1356 - Tablet TFIIbDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1356 - Tablet TFII | Experimental | Not described Receives: Drug: BI 1356 - Tablet TFII; Drug: BI 1356 - Tablet iFF; Drug: BI 1356 - Tablet TFIIb |
| BI 1356 - Tablet iFF | Experimental | Not described Receives: Drug: BI 1356 - Tablet TFII; Drug: BI 1356 - Tablet iFF; Drug: BI 1356 - Tablet TFIIb |
| BI 1356 - Tablet TFIIb | Active comparator | Not described Receives: Drug: BI 1356 - Tablet TFII; Drug: BI 1356 - Tablet iFF; Drug: BI 1356 - Tablet TFIIb |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours)
Measured: predose, up to 24 hours
Secondary outcomes (19)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: predose, up to 264 hours
C24 (plasma concentration of the analyte 24 hours after dosing)
Measured: predose, up to 264 hours
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: predose, up to 264 hours
λz (terminal rate constant in plasma)
Measured: predose, up to 264 hours
t1/2 (terminal half-life of the analyte in plasma)
Measured: predose, up to 264 hours
MRTpo (mean residence time of the analyte in the body after po administration)
Measured: predose, up to 264 hours
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: predose, up to 264 hours
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: predose, up to 264 hours
Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma
Measured: predose, up to 264 hours
Changes in plasma glucose levels
Measured: predose, up to 264 hours
Number of patients with adverse events
Measured: up to 18 days following last drug administration
Number of patients with abnormal findings in physical examination
Measured: up to 18 days following last drug administration
Number of patients with clinically significant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))
Measured: up to 18 days following last drug administration
Number of patients with abnormal changes 12-lead ECG (electrocardiogram)
Measured: up to 18 days following last drug administration
Number of patients with abnormal changes in laboratory parameters
Measured: up to 18 days following last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 18 days following last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183363
- Sponsor's protocol ID
- 1218.25
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02183363
- Acronym / sponsor ID
- 1218.25
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 1356 - Tablet TFII | Experimental | Drug: BI 1356 - Tablet TFII, Drug: BI 1356 - Tablet iFF, Drug: BI 1356 - Tablet TFIIb |
| BI 1356 - Tablet iFF | Experimental | Drug: BI 1356 - Tablet TFII, Drug: BI 1356 - Tablet iFF, Drug: BI 1356 - Tablet TFIIb |
| BI 1356 - Tablet TFIIb | Active comparator | Drug: BI 1356 - Tablet TFII, Drug: BI 1356 - Tablet iFF, Drug: BI 1356 - Tablet TFIIb |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1356 - Tablet TFII | Drug | BI 1356 - Tablet TFII, BI 1356 - Tablet TFIIb, BI 1356 - Tablet iFF |
| BI 1356 - Tablet iFF | Drug | BI 1356 - Tablet TFII, BI 1356 - Tablet TFIIb, BI 1356 - Tablet iFF |
| BI 1356 - Tablet TFIIb | Drug | BI 1356 - Tablet TFII, BI 1356 - Tablet TFIIb, BI 1356 - Tablet iFF |
Primary outcome
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
19 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 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
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
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
C24 (plasma concentration of the analyte 24 hours after dosing)
Time frame: 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
λz (terminal rate constant in plasma)
Time frame: predose, up to 264 hours
t1/2 (terminal half-life of the analyte in plasma)
Time frame: 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
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: 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
Changes in Dipeptidyl-peptidase-IV (DPP-IV) activity in plasma
Time frame: predose, up to 264 hours
Changes in plasma glucose levels
Time frame: predose, up to 264 hours
Number of patients with adverse events
Time frame: 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
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
Number of patients with abnormal changes 12-lead ECG (electrocardiogram)
Time frame: 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
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 18 days following last drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1356 - Tablet TFII, BI 1356 - Tablet iFF and BI 1356 - Tablet TFIIb in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.