HealthyPhase 1NCT02172105
Multiple Rising Inhalative Doses of BI 1744 CL in Healthy Male Volunteers
A Phase 1 study testing BI 1744 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1744 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to May 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
- Subjects must be able to inhale medication in a competent manner from the Respimat®inhaler
Who cannot join
- Any finding of the medical examination (including ,blood pressure and pulse rate 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 23Show fewer
- Chronic or relevant acute infections
- 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 before drug administration or during the trial
- Use of prescription or non-prescription drugs within 10 days before drug administration or during the trial. However, over-the-counter drugs for external application (such as lubricant eye drops for contact lens, insect bite reliever) shall be allowed
- Participation in another trial with an investigational drug within four months before drug 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: corresponds to ca. 3 large bottles of beer, 3 gous (ca. 540 cc) of Japanese sake, 6 shots of whisky, 6 glasses of wine or 6 glasses of Japanese shochu, distilled alcoholic beverage)
- Drug abuse
- Blood donation (more than 100 mL within four weeks before drug administration or during the trial)
- Excessive physical activities (within one week before 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) or long QT syndroms
- A history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia) or other cardiac arrhythmias
- hyperthyroidism
- Disagree with adequate contraception (the subject should use condoms and his partner should use oral contraception or intrauterine device [IUD]) during the study
About this study
Official title: A Double-blind, Randomised, Placebo Controlled (Within a Dose Group) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (5 μg, 10 μg and 20 μg) of BI 1744 CL for 14 Days in Healthy Male Volunteers
Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers.
- Conditions
- Healthy
- Being tested
- BI 1744 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1744 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL | Experimental | Not described Receives: Drug: BI 1744 CL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with abnormal findings in physical examination
Measured: Baseline, up to 13 days after last drug administration
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
Measured: Baseline, up to 13 days after last drug administration
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Measured: Baseline, up to 13 days after last drug administration
Number of patients with clinically significant changes in clinical laboratory tests
Measured: Baseline, up to 13 days after last drug administration
Change from baseline in potassium level
Measured: Baseline and Day 14
Number of patients with adverse events
Measured: 7 weeks
Assessment of tolerability on a 4-point scale
Measured: Day 28
Secondary outcomes (17)
Cmax (maximum measured concentration of the analyte in plasma at different time points)
Measured: Up to day 18
tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points)
Measured: Up to day 18
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Measured: Up to day 18
%AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation)
Measured: Up to day 18
λz (terminal rate constant in plasma at different time points)
Measured: Up to day 18
t1/2 (terminal half-life of the analyte in plasma at different time points)
Measured: Up to day 18
MRTih (mean residence time of the analyte in the body after inhalation administration at different time points)
Measured: Up to day 18
Aeτ (amount of analyte that is eliminated in urine after administration over a uniform dosing interval τ at different time points)
Measured: Up to day 18
feτ (fraction of analyte eliminated in urine after administration over a uniform dosing interval τ at different time points)
Measured: Up to day 18
CLR (renal clearance of the analyte at different time points)
Measured: Up to day 18
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Up to day 18
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Measured: Up to day 18
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Up to day 18
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Measured: Up to day 18
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: Up to day 18
Accumulation ratio (RA,AUC)
Measured: Up to day 18
Accumulation ratio (RA,Cmax)
Measured: Up to day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2008
- Primary completionMay 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 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
- NCT02172105
- Sponsor's protocol ID
- 1222.21
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo Controlled (Within a Dose Group) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhalative Doses (5 μg, 10 μg and 20 μg) of BI 1744 CL for 14 Days in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02172105
- Acronym / sponsor ID
- 1222.21
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- First posted
- 24 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.
Study to evaluate safety, tolerability, and pharmacokinetics of BI 1744 CL in healthy Japanese male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL | Experimental | Drug: BI 1744 CL |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Japanese men: According to the results of a complete medical history, the physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory tests
- Age ≥20 and ≤35 years
- Body mass index (BMI) ≥18.5 and ≤25.0 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
- Subjects must be able to inhale medication in a competent manner from the Respimat®inhaler
Key exclusion criteria (23 listed)
- Any finding of the medical examination (including ,blood pressure and pulse rate 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 1744 CL | Drug | BI 1744 CL |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with abnormal findings in physical examination
Time frame: Baseline, up to 13 days after last drug administration
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
Time frame: Baseline, up to 13 days after last drug administration
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Time frame: Baseline, up to 13 days after last drug administration
Number of patients with clinically significant changes in clinical laboratory tests
Time frame: Baseline, up to 13 days after last drug administration
Change from baseline in potassium level
Time frame: Baseline and Day 14
Number of patients with adverse events
Time frame: 7 weeks
Assessment of tolerability on a 4-point scale
Time frame: Day 28
17 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma at different time points)
Time frame: Up to day 18
tmax (time from dosing to maximum measured concentration of the analyte in plasma at different time points)
Time frame: Up to day 18
AUC (area under the concentration-time curve of the analyte in plasma at different time points)
Time frame: Up to day 18
%AUCtz-∞ (the percentage of the AUC 0-infinity that is obtained by extrapolation)
Time frame: Up to day 18
λz (terminal rate constant in plasma at different time points)
Time frame: Up to day 18
t1/2 (terminal half-life of the analyte in plasma at different time points)
Time frame: Up to day 18
MRTih (mean residence time of the analyte in the body after inhalation administration at different time points)
Time frame: Up to day 18
Aeτ (amount of analyte that is eliminated in urine after administration over a uniform dosing interval τ at different time points)
Time frame: Up to day 18
feτ (fraction of analyte eliminated in urine after administration over a uniform dosing interval τ at different time points)
Time frame: Up to day 18
CLR (renal clearance of the analyte at different time points)
Time frame: Up to day 18
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to day 18
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: Up to day 18
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to day 18
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Time frame: Up to day 18
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: Up to day 18
Accumulation ratio (RA,AUC)
Time frame: Up to day 18
Accumulation ratio (RA,Cmax)
Time frame: Up to day 18
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 24 Jun 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 1744 CL 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 5 inclusion and 23 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 24 Jun 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. Some participants in this study may receive a placebo. 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?
Number of patients with abnormal findings in physical examination (time frame: Baseline, up to 13 days after last drug administration). The study lists 7 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 24 Jun 2014.