HealthyPhase 1NCT02183506
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
A Phase 1 study testing Metformin and BI 1356 BS in people with Healthy, run by Boehringer Ingelheim.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Metformin and BI 1356 BS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
BI 1356 BSDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Not described Receives: Drug: Metformin |
| BI 1356 BS and metformin | Experimental | 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) Receives: Drug: Metformin; Drug: BI 1356 BS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) of the analytes in plasma at different time points
Measured: up to 240 hours after start of treatment
Maximum concentration (Cmax) of the analytes in plasma at different time points
Measured: up to 240 hours after start of treatment
Secondary outcomes (13)
Time from last dosing to maximum concentration of the analytes in plasma at steady state (tmax,ss)
Measured: 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
Measured: up to 240 hours after start of treatment
Terminal rate constant of the analytes in plasma at steady state (λz,ss )
Measured: up to 240 hours after start of treatment
Terminal half-life of the analytes in plasma at steady state (t1/2,ss )
Measured: 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)
Measured: 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
Measured: 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
Measured: up to 240 hours after start of treatment
Measurements of dipeptidylpeptidase 4 (DPP-IV) activity
Measured: up to 240 hours after start of treatment
Number of patients with adverse events
Measured: up to 60 days
Number of patients with clinically abnormal changes in laboratory values
Measured: Baseline, up to 14 days after last drug administration
Number of patients with clinically relevant changes in vital signs
Measured: Baseline, up to 14 days after last drug administration
feτ,ss (fraction of the dose excreted unchanged in urine at steady state)
Measured: 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)
Measured: 0-4 h, 4-8 h, 8-12 h and 12-24 hours after drug administration on days 3, 6, 9
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 startSep 2005
- Primary completionDec 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
- 16 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
- NCT02183506
- Sponsor's protocol ID
- 1218.4
- 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 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)
- ClinicalTrials.gov ID
- NCT02183506
- Acronym / sponsor ID
- 1218.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin |
| BI 1356 BS and metformin | Experimental | Drug: Metformin, Drug: BI 1356 BSDaily 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) |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Metformin | Drug | BI 1356 BS and metformin, Metformin |
| BI 1356 BS | Drug | BI 1356 BS and metformin |
Primary outcome
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
Maximum concentration (Cmax) of the analytes in plasma at different time points
Time frame: up to 240 hours after start of treatment
13 secondary outcomes
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
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
Terminal rate constant of the analytes in plasma at steady state (λz,ss )
Time frame: 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
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
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
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
Measurements of dipeptidylpeptidase 4 (DPP-IV) activity
Time frame: up to 240 hours after start of treatment
Number of patients with adverse events
Time frame: 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
Number of patients with clinically relevant changes in vital signs
Time frame: 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
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
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 Metformin and BI 1356 BS 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?
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). 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.