HealthyPhase 1NCT02180503
Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS
A Phase 1 study testing BI 1356 BS PIB - low dose, BI 1356 BS tablet - low dose and BI 1356 BS PIB - high dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1356 BS PIB - low dose, BI 1356 BS tablet - low dose and BI 1356 BS PIB - high dose
- 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
- Aug 2005to Oct 2005
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older 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 ≤65 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 18Show 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
- No adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
About this study
Official title: Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) Reconstituted With 0.1% Tartaric Acid Compared to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers (Separately at Each Dose Level) Including the Influence of Food (Standardised High Fat Breakfast) on the Bioavailability of 10 mg BI 1356 BS as Tablet in a Single Dose, Open-label, Randomised, Two-way (1 mg) and Three-way (10 mg) Crossover Trial
Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group
- Conditions
- Healthy
- Being tested
- BI 1356 BS PIB - low dose, BI 1356 BS tablet - low dose, BI 1356 BS PIB - high dose, BI 1356 BS tablet - high dose, BI 1356 BS tablet - high dose with food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1356 BS PIB - low doseDrug
BI 1356 BS tablet - low doseDrug
BI 1356 BS PIB - high doseDrug
BI 1356 BS tablet - high doseDrug
BI 1356 BS tablet - high dose with foodDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1356 BS - low dose | Experimental | Not described Receives: Drug: BI 1356 BS PIB - low dose; Drug: BI 1356 BS tablet - low dose |
| BI 1356 BS - high dose | Experimental | Not described Receives: Drug: BI 1356 BS PIB - high dose; Drug: BI 1356 BS tablet - high dose; Drug: BI 1356 BS tablet - high dose with food |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Measured: Up to 264 h after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 264 h after drug administration
Secondary outcomes (11)
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: Up to 264 h after drug administration
AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Measured: Up to 264 h after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: Up to 264 h after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 264 h after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: Up to 264 h after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: Up to 264 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Up to 264 h after drug administration
Number of patients with adverse events
Measured: Up to 18 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: Up to 18 days after last drug administration
Clinically relevant changes in clinical laboratory values
Measured: Up to 18 days after last drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: Up to 264 h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startAug 2005
- Primary completionOct 2005
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
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180503
- Sponsor's protocol ID
- 1218.8
- Status last verified
- Jul 2014
- First submitted
- 1 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
- Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) Reconstituted With 0.1% Tartaric Acid Compared to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers (Separately at Each Dose Level) Including the Influence of Food (Standardised High Fat Breakfast) on the Bioavailability of 10 mg BI 1356 BS as Tablet in a Single Dose, Open-label, Randomised, Two-way (1 mg) and Three-way (10 mg) Crossover Trial
- ClinicalTrials.gov ID
- NCT02180503
- Acronym / sponsor ID
- 1218.8
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Oct 2005 (actual)
- First posted
- 2 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.
Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1356 BS - low dose | Experimental | Drug: BI 1356 BS PIB - low dose, Drug: BI 1356 BS tablet - low dose |
| BI 1356 BS - high dose | Experimental | Drug: BI 1356 BS PIB - high dose, Drug: BI 1356 BS tablet - high dose, Drug: BI 1356 BS tablet - high dose with food |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 ≤65 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 (18 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 BS PIB - low dose | Drug | BI 1356 BS - low dose |
| BI 1356 BS tablet - low dose | Drug | BI 1356 BS - low dose |
| BI 1356 BS PIB - high dose | Drug | BI 1356 BS - high dose |
| BI 1356 BS tablet - high dose | Drug | BI 1356 BS - high dose |
| BI 1356 BS tablet - high dose with food | Drug | BI 1356 BS - high dose |
Primary outcome
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Time frame: Up to 264 h after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 264 h after drug administration
11 secondary outcomes
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: Up to 264 h after drug administration
AUCt1-t2 (Partial area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: Up to 264 h after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Up to 264 h after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 264 h after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 264 h after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 264 h after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 264 h after drug administration
Number of patients with adverse events
Time frame: Up to 18 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: Up to 18 days after last drug administration
Clinically relevant changes in clinical laboratory values
Time frame: Up to 18 days after last drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: Up to 264 h after 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.
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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 BS PIB - low dose, BI 1356 BS tablet - low dose and BI 1356 BS PIB - high dose 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 18 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-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (time frame: Up to 264 h after drug administration). The study lists 2 primary outcomes in all. 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.