HealthyPhase 1NCT02173652
Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers
A Phase 1 study testing BI 1356, high dose and BI 1356, low dose in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective was to investigate the influence of 2 different dosage regimens (5 mg once daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of orally administered BI 1356. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1356, high dose and BI 1356, low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Apr 2008
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females and males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 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 and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- 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
Show all 29Show fewer
- Chronic or relevant acute infections (e.g. HIV)
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- 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 or that prolong the QT/QTc interval 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 trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- A history of additional risk factors for torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- For male subjects:
- Not willing to use adequate contraception (condome use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, IUD (intrauterine device)) during the whole study period from the time of the first intake of study drug until one month after the last intake
- For female subjects:
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test
- Are not willing or are unable to use a reliable method of contraception (such as implants, injectibles and combined oral contraceptives, sterilisation, IUD, double barrier method) for at least 3 months prior to participation in the trial, during and up to 2 months after completion/termination of the trial
- Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception
- Lactation period
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers. A Monocentric, Open Label, Cross-over Trial
The objective was to investigate the influence of 2 different dosage regimens (5 mg once daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of orally administered BI 1356.
- Conditions
- Healthy
- Being tested
- BI 1356, high dose, BI 1356, low dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1356, high doseDrug
BI 1356, low doseDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1356, high dose | Experimental | Treatment A: 7 days of BI 1356 treatment given once daily Receives: Drug: BI 1356, high dose |
| BI 1356, low dose | Active comparator | Treatment B: 7 days of BI 1356 treatment given twice daily Receives: Drug: BI 1356, low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24,ss (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state)
Measured: up to 336 h after first administration of study drug
Secondary outcomes (16)
Cmax,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval)
Measured: up to 336 h after first administration of study drug
Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered)
Measured: up to 336 h after first administration of study drug
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 336 h after first administration of study drug
AUCss (area under the concentration-time curve of the analyte in plasma at steady state) for several time points
Measured: up to 336 h after first administration of study drug
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Measured: up to 336 h after first administration of study drug
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Measured: up to 336 h after first administration of study drug
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Measured: up to 336 h after first administration of study drug
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: up to 336 h after first administration of study drug
Aet1-t2 (amount of BI 1356 excreted in the urine over the time interval t1 to t2 at steady-state)
Measured: 0-12h and 12-24h after drug administration on day 7 and day 14
fet1-t2 (fraction of BI 1356 excreted in urine over the time interval form t1 to t2)
Measured: 0-12h and 12-24h after drug administration on day 7 and day 14
Number of patients with clinically relevant findings in vital signs (blood pressure (BP), pulse rate (PR))
Measured: Baseline, up to 26 days
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Measured: Baseline, up to 26 days
Number of patients with clinically relevant findings in clinical laboratory tests
Measured: Baseline, up to 26 days
Incidence of adverse events (AEs)
Measured: up to 47 days
Assessment of tolerability on a 4-point scale by investigator
Measured: Day 7, 15 and 26
Dipeptidyl peptidase-4 (DPP-4) inhibition at steady state
Measured: up to 336 h after first administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMar 2008
- Primary completionApr 2008
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
- NCT02173652
- Sponsor's protocol ID
- 1218.45
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 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
- Pharmacokinetics and Pharmacodynamics of Multiple 5 mg Doses of BI 1356 p.o. Given Once Daily Compared to Multiple 2.5 mg Doses Given Twice Daily in Healthy Male and Female Volunteers. A Monocentric, Open Label, Cross-over Trial
- ClinicalTrials.gov ID
- NCT02173652
- Acronym / sponsor ID
- 1218.45
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- First posted
- 25 Jun 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.
The objective was to investigate the influence of 2 different dosage regimens (5 mg once daily vs. 2.5 mg twice daily) on the steady-state pharmacokinetics and pharmacodynamics of orally administered BI 1356.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1356, high dose | Experimental | Drug: BI 1356, high doseTreatment A: 7 days of BI 1356 treatment given once daily |
| BI 1356, low dose | Active comparator | Drug: BI 1356, low doseTreatment B: 7 days of BI 1356 treatment given twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy females and males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥18 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 and the local legislation
Key exclusion criteria (29 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- 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
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, high dose | Drug | BI 1356, high dose |
| BI 1356, low dose | Drug | BI 1356, low dose |
Primary outcome
AUC0-24,ss (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state)
Time frame: up to 336 h after first administration of study drug
16 secondary outcomes
Cmax,ss (concentration of the analyte in plasma at steady state after administration of the last dose at the end of the dosing interval)
Time frame: up to 336 h after first administration of study drug
Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered)
Time frame: up to 336 h after first administration of study drug
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 336 h after first administration of study drug
AUCss (area under the concentration-time curve of the analyte in plasma at steady state) for several time points
Time frame: up to 336 h after first administration of study drug
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: up to 336 h after first administration of study drug
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: up to 336 h after first administration of study drug
CLR,ss (renal clearance of the analyte at steady state determined over the dosing interval τ)
Time frame: up to 336 h after first administration of study drug
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: up to 336 h after first administration of study drug
Aet1-t2 (amount of BI 1356 excreted in the urine over the time interval t1 to t2 at steady-state)
Time frame: 0-12h and 12-24h after drug administration on day 7 and day 14
fet1-t2 (fraction of BI 1356 excreted in urine over the time interval form t1 to t2)
Time frame: 0-12h and 12-24h after drug administration on day 7 and day 14
Number of patients with clinically relevant findings in vital signs (blood pressure (BP), pulse rate (PR))
Time frame: Baseline, up to 26 days
Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram)
Time frame: Baseline, up to 26 days
Number of patients with clinically relevant findings in clinical laboratory tests
Time frame: Baseline, up to 26 days
Incidence of adverse events (AEs)
Time frame: up to 47 days
Assessment of tolerability on a 4-point scale by investigator
Time frame: Day 7, 15 and 26
Dipeptidyl peptidase-4 (DPP-4) inhibition at steady state
Time frame: up to 336 h after first administration of study drug
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, high dose and BI 1356, low 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 4 inclusion and 29 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,ss (area under the concentration-time curve of the analyte in plasma over the time interval 0 to 24 hours at steady state) (time frame: up to 336 h after first administration of study drug). 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; AzTrials last refreshed its copy on 8 Nov 2026.