HealthyPhase 1NCT02259959
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide in Healthy Male Volunteers
A Phase 1 study testing Single rising doses of BI 1744 CL, solution for oral inhalation and Tiotropium, fixed dose, solution for oral inhalation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single rising doses of BI 1744 CL, solution for oral inhalation and Tiotropium, fixed dose, solution for oral inhalation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Sep 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male based upon a complete medical history, including physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease
- Age ≥21 and ≤45 years
- BMI ≥18.5 and <30 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
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- 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
Show all 29Show fewer
- History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization
- 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 randomisation
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 40 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomisation or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
- The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
- The following exclusion criteria are specific for this study due to the known class side effect profile of Tiotropium:
- Hypersensitivity to tiotropium and/or related drugs of these classes
- History of narrow-angle glaucoma
- History of prostatic hyperplasia
- History of bladder-neck obstruction
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2 μg/5 μg, 10 μg/5 μg, and 40 μg/10 μg) of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide for 14 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] Study)
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination
- Conditions
- Healthy
- Being tested
- Single rising doses of BI 1744 CL, solution for oral inhalation, Tiotropium, fixed dose, solution for oral inhalation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single rising doses of BI 1744 CL, solution for oral inhalationDrug
Tiotropium, fixed dose, solution for oral inhalationDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL in combination with Tiotropium | Experimental | Not described Receives: Drug: Single rising doses of BI 1744 CL, solution for oral inhalation; Drug: Tiotropium, fixed dose, solution for oral inhalation |
| 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 subjects with clinically relevant findings in physical examination
Measured: Up to day 32
Number of subjects with clinically relevant findings in vital signs
blood pressure, pulse rate
Measured: Up to day 32
Number of subjects with clinically relevant findings in 12-lead ECG
Measured: Up to day 32
Number of subjects with clinically relevant findings in laboratory tests
Measured: Up to day 32
Number of subjects witch clinically relevant changes in additional safety laboratory test parameters
Systemic metabolic parameters: cyclic adenosine mono phosphate (cAMP) and potassium
Measured: up to 318 hours after start of treatment
Number of subjects with clinically relevant changes in airway resistance (Raw) measured by body plethysmography
Measured: Pre-dose, up to 408 hours after start of treatment
Number of subjects with adverse events
Measured: Up to day 32
Global assessment of tolerability by investigator on a 4-point scale
Measured: Up to day 32
Secondary outcomes (19)
Maximum concentration in plasma (Cmax)
Measured: up to 504 hours after start of treatment
Time from dosing to maximum concentration in plasma (tmax)
Measured: up to 504 hours after start of treatment
Area under the concentration-time curve in plasma (AUC)
Measured: up to 504 hours after start of treatment
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 504 hours after start of treatment
Percentage of AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
Measured: up to 504 hours after start of treatment
Terminal rate constant in plasma (λz)
Measured: up to 504 hours after start of treatment
Terminal half-life in plasma (t½)
Measured: up to 504 hours after start of treatment
Mean residence time in the body after inhalation (MRTih)
Measured: up to 504 hours after start of treatment
Apparent clearance after extravascular administration (CL/F)
Measured: up to 504 hours after start of treatment
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: up to 504 hours after start of treatment
Amount eliminated in urine from the time point t1 to t2 (Aet1-t2)
Measured: up to 336 hours after start of treatment
Fraction excreted in urine from time point t1 to t2 (fet1-t2)
Measured: up to 336 hours after start of treatment
Renal clearance from the time point t1 until the time point t2 (CLR,t1-t2)
Measured: up to 504 hours after start of treatment
Minimum measured concentration in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: up to 504 hours after start of treatment
Predose concentration of the analytes in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: Pre-dose every 24 hours
Time of last measurable concentration in plasma (tz)
Measured: up to 504 hours after start of treatment
Linearity index (LI)
Measured: up to 504 hours after start of treatment
Accumulation ratio based on Cmax (RA,Cmax)
Measured: up to 504 hours after start of treatment
Accumulation ratio based on AUCτ (RA,AUC)
Measured: up to 504 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startApr 2007
- Primary completionSep 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
- 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
- NCT02259959
- Sponsor's protocol ID
- 1237.2
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses (2 μg/5 μg, 10 μg/5 μg, and 40 μg/10 μg) of BI 1744 CL in Fixed Dose Combination With Tiotropium Bromide for 14 Days in Healthy Male Volunteers (Double-blind, Randomised, Placebo Controlled [at Each Dose Level] Study)
- ClinicalTrials.gov ID
- NCT02259959
- Acronym / sponsor ID
- 1237.2
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2007 (actual)
- First posted
- 9 Oct 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.
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL and Tiotropium Bromide when given as fixed dose combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL in combination with Tiotropium | Experimental | Drug: Single rising doses of BI 1744 CL, solution for oral inhalation, Drug: Tiotropium, fixed dose, solution for oral inhalation |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male based upon a complete medical history, including physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease
- Age ≥21 and ≤45 years
- BMI ≥18.5 and <30 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 (29 listed)
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Single rising doses of BI 1744 CL, solution for oral inhalation | Drug | BI 1744 CL in combination with Tiotropium |
| Tiotropium, fixed dose, solution for oral inhalation | Drug | BI 1744 CL in combination with Tiotropium |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with clinically relevant findings in physical examination
Time frame: Up to day 32
Number of subjects with clinically relevant findings in vital signs
Time frame: Up to day 32
blood pressure, pulse rate
Number of subjects with clinically relevant findings in 12-lead ECG
Time frame: Up to day 32
Number of subjects with clinically relevant findings in laboratory tests
Time frame: Up to day 32
Number of subjects witch clinically relevant changes in additional safety laboratory test parameters
Time frame: up to 318 hours after start of treatment
Systemic metabolic parameters: cyclic adenosine mono phosphate (cAMP) and potassium
Number of subjects with clinically relevant changes in airway resistance (Raw) measured by body plethysmography
Time frame: Pre-dose, up to 408 hours after start of treatment
Number of subjects with adverse events
Time frame: Up to day 32
Global assessment of tolerability by investigator on a 4-point scale
Time frame: Up to day 32
19 secondary outcomes
Maximum concentration in plasma (Cmax)
Time frame: up to 504 hours after start of treatment
Time from dosing to maximum concentration in plasma (tmax)
Time frame: up to 504 hours after start of treatment
Area under the concentration-time curve in plasma (AUC)
Time frame: up to 504 hours after start of treatment
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 504 hours after start of treatment
Percentage of AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
Time frame: up to 504 hours after start of treatment
Terminal rate constant in plasma (λz)
Time frame: up to 504 hours after start of treatment
Terminal half-life in plasma (t½)
Time frame: up to 504 hours after start of treatment
Mean residence time in the body after inhalation (MRTih)
Time frame: up to 504 hours after start of treatment
Apparent clearance after extravascular administration (CL/F)
Time frame: up to 504 hours after start of treatment
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 504 hours after start of treatment
Amount eliminated in urine from the time point t1 to t2 (Aet1-t2)
Time frame: up to 336 hours after start of treatment
Fraction excreted in urine from time point t1 to t2 (fet1-t2)
Time frame: up to 336 hours after start of treatment
Renal clearance from the time point t1 until the time point t2 (CLR,t1-t2)
Time frame: up to 504 hours after start of treatment
Minimum measured concentration in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 504 hours after start of treatment
Predose concentration of the analytes in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: Pre-dose every 24 hours
Time of last measurable concentration in plasma (tz)
Time frame: up to 504 hours after start of treatment
Linearity index (LI)
Time frame: up to 504 hours after start of treatment
Accumulation ratio based on Cmax (RA,Cmax)
Time frame: up to 504 hours after start of treatment
Accumulation ratio based on AUCτ (RA,AUC)
Time frame: up to 504 hours after start of treatment
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 9 Oct 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 Single rising doses of BI 1744 CL, solution for oral inhalation and Tiotropium, fixed dose, solution for oral inhalation 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 9 Oct 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 subjects with clinically relevant findings in physical examination (time frame: Up to day 32). The study lists 8 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 9 Oct 2014.