HealthyPhase 1NCT02259946
Study to Investigate Safety and Tolerability of BI 1744 CL in Free Dose Combination With Tiotropium Bromide Both Administered by Respimat® in Healthy Male Volunteers
A Phase 1 study testing BI 1744 CL and Tiotropium bromide in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744 CL), both administered by Respimat® in… 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?
- BI 1744 CL and Tiotropium bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jul 2006
- 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 male based upon a complete medical history, including the physical examination, regarding vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. Absence of any clinically relevant abnormality. Absence of any clinically relevant concomitant disease
- Age ≥21 and ≤50 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 enrolment in the study or during the study
- Participation in another trial with an investigational drug within 2 months prior to randomization
- 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 (regularly more than 40 g alcohol per day for men)
- 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 randomization 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
- Additionally, following exclusion criteria that are of particular relevance with regard to the known properties of BI 1744 CL as a ß-adrenoceptor agonist must be adhered to:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia
- Furthermore, the following exclusion criteria that are of particular relevance with regard to the known properties of tiotropium as an antimuscarinic anticholinergic agent must be adhered to:
- 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: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL (Administered With the Respimat®) in Free Dose Combination With Tiotropium Bromide 5 μg ( for Doses up to and Including 20 μg BI 1744 CL), 10 μg (for Doses of 20 μg and 40 μg BI 1744 CL) (Administered With the Respimat®) in Healthy Male Volunteers
Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744 CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their dose proportionality, and to explore the pharmacodynamic effects of the treatments on selected metabolic and respiratory parameters
- Conditions
- Healthy
- Being tested
- BI 1744 CL, Placebo, Tiotropium bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1744 CLDrug
PlaceboDrug
Tiotropium bromideDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL - single rising dose + Tiotropium | Experimental | Single rising dose of BI 1744 CL (conjointly with Tiotropium bromide) Receives: Drug: BI 1744 CL; Drug: Tiotropium bromide |
| 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 participants with abnormal findings in physical examination
Measured: up to 12 days after drug administration
Number of participants with abnormal changes in laboratory parameters
Measured: up to 12 days after drug administration
Number of participants with clinically significant changes in vital signs
blood pressure (BP), pulse rate (PR), respiratory rate (RR)
Measured: up to 12 days after drug administration
Number of participants with adverse events
Measured: up to 12 days after drug administration
Number of participants with clinically significant changes in 12-lead ECG
cardiac axis, heart rate, PQ interval, QRS interval, uncorrected QT interval, HR-corrected QT-interval according to Bazett and Fridericia
Measured: up to 12 days after drug administration
Number of abnormal findings on oropharyngeal inspection
Measured: up to 24 hours after drug administration
Number of abnormal findings on pulmonary auscultation
Measured: up to 24 hours after drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: 12 days after drug administration
Change in Airway resistance (Raw)
measured by whole-body plethysmography
Measured: up to 24 hours after drug administration
Change in specific conductance (sGaw)
measured by whole-body plethysmography
Measured: up to 24 hours after drug administration
Change in Cyclic aminomonophosphate (cAMP)
Measured: up to 6 hours after drug administration
Change in potassium
Measured: up to 6 hours after drug administration
Secondary outcomes (13)
Cmax (maximum measured concentration of BI 1744 BS and tiotropium in plasma)
Measured: up to 96 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Measured: up to 96 hours after drug administration
AUC0-∞ (area under the concentration-time curve of BI 1744 BS and tiotropium in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 96 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: up to 96 hours after drug administration
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Measured: up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Measured: up to 96 hours after drug administration
t1/2 (terminal half-life of BI 1744 BS and tiotropium in plasma)
Measured: up to 96 hours after drug administration
MRTih (mean residence time of BI 1744 BS and tiotropium in the body after inhalation)
Measured: up to 96 hours after drug administration
CL/F (apparent clearance of BI 1744 BS and tiotropium in plasma after extravascular administration)
Measured: up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 96 hours after drug administration
Aet1-t2 (amount of BI 1744 BS and tiotropium eliminated in urine from the time point t1 to time point t2)
Measured: up to 96 hours after drug administration
fet1-t2 (fraction of BI 1744 BS and tiotropium eliminated in urine from time point t1 to time point t2)
Measured: up to 96 hours after drug administration
CLR,t1-t2 (renal clearance of BI 1744 BS and tiotropium from the time point t1 until the time point t2)
Measured: up to 96 hours 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 posted9 Oct 2014 (estimated)
- Study startApr 2006
- Primary completionJul 2006
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
- 48 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
- NCT02259946
- Sponsor's protocol ID
- 1237.1
- 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
- A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL (Administered With the Respimat®) in Free Dose Combination With Tiotropium Bromide 5 μg ( for Doses up to and Including 20 μg BI 1744 CL), 10 μg (for Doses of 20 μg and 40 μg BI 1744 CL) (Administered With the Respimat®) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02259946
- Acronym / sponsor ID
- 1237.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2006 (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.
Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg, 20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744 CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their dose proportionality, and to explore the pharmacodynamic effects of the treatments on selected metabolic and respiratory parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL - single rising dose + Tiotropium | Experimental | Drug: BI 1744 CL, Drug: Tiotropium bromideSingle rising dose of BI 1744 CL (conjointly with Tiotropium bromide) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. Absence of any clinically relevant abnormality. Absence of any clinically relevant concomitant disease
- Age ≥21 and ≤50 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 |
|---|---|---|
| BI 1744 CL | Drug | BI 1744 CL - single rising dose + Tiotropium |
| Placebo | Drug | Placebo |
| Tiotropium bromide | Drug | BI 1744 CL - single rising dose + Tiotropium |
Primary outcome
Number of participants with abnormal findings in physical examination
Time frame: up to 12 days after drug administration
Number of participants with abnormal changes in laboratory parameters
Time frame: up to 12 days after drug administration
Number of participants with clinically significant changes in vital signs
Time frame: up to 12 days after drug administration
blood pressure (BP), pulse rate (PR), respiratory rate (RR)
Number of participants with adverse events
Time frame: up to 12 days after drug administration
Number of participants with clinically significant changes in 12-lead ECG
Time frame: up to 12 days after drug administration
cardiac axis, heart rate, PQ interval, QRS interval, uncorrected QT interval, HR-corrected QT-interval according to Bazett and Fridericia
Number of abnormal findings on oropharyngeal inspection
Time frame: up to 24 hours after drug administration
Number of abnormal findings on pulmonary auscultation
Time frame: up to 24 hours after drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 12 days after drug administration
Change in Airway resistance (Raw)
Time frame: up to 24 hours after drug administration
measured by whole-body plethysmography
Change in specific conductance (sGaw)
Time frame: up to 24 hours after drug administration
measured by whole-body plethysmography
Change in Cyclic aminomonophosphate (cAMP)
Time frame: up to 6 hours after drug administration
Change in potassium
Time frame: up to 6 hours after drug administration
13 secondary outcomes
Cmax (maximum measured concentration of BI 1744 BS and tiotropium in plasma)
Time frame: up to 96 hours after drug administration
tmax (time from dosing to maximum measured concentration)
Time frame: up to 96 hours after drug administration
AUC0-∞ (area under the concentration-time curve of BI 1744 BS and tiotropium in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte salmeterol in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 96 hours after drug administration
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Time frame: up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 96 hours after drug administration
t1/2 (terminal half-life of BI 1744 BS and tiotropium in plasma)
Time frame: up to 96 hours after drug administration
MRTih (mean residence time of BI 1744 BS and tiotropium in the body after inhalation)
Time frame: up to 96 hours after drug administration
CL/F (apparent clearance of BI 1744 BS and tiotropium in plasma after extravascular administration)
Time frame: up to 96 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 96 hours after drug administration
Aet1-t2 (amount of BI 1744 BS and tiotropium eliminated in urine from the time point t1 to time point t2)
Time frame: up to 96 hours after drug administration
fet1-t2 (fraction of BI 1744 BS and tiotropium eliminated in urine from time point t1 to time point t2)
Time frame: up to 96 hours after drug administration
CLR,t1-t2 (renal clearance of BI 1744 BS and tiotropium from the time point t1 until the time point t2)
Time frame: up to 96 hours 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 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 BI 1744 CL and Tiotropium bromide 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 participants with abnormal findings in physical examination (time frame: up to 12 days after drug administration). The study lists 12 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.