HealthyPhase 1NCT02171793
Single Rising Peroral Doses of BI 1744 CL in Healthy Volunteers
A Phase 1 study testing BI 1744 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BI 1744 CL. 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?
- BI 1744 CL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jul 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 males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- 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 24Show 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 randomisation
- 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 30 days 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 (regularly more than 40 g alcohol per 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 β2 mimetic drugs:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
About this study
Official title: A Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Peroral Doses (15, 30, 40 μg Free Cation) BI 1744 CL in Healthy Male Volunteers
Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BI 1744 CL.
- 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, day 17
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature)
Measured: Baseline, up to day 17
Number of patients with clinically relevant abnormal findings in 12-lead electrocardiogram (ECG)
Measured: Baseline, up to day 17
Number of patients with clinically significant changes in clinical laboratory tests
Measured: Baseline, up to day 17
Number of patients with Adverse events (AEs)
Measured: 5 weeks
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 17
Secondary outcomes (13)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
λz (terminal rate constant in plasma)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after peroral administration)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after peroral administration, will not be calculated for metabolites)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following a peroral dose, will not be calculated for metabolites)
Measured: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Measured: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h 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 posted24 Jun 2014 (estimated)
- Study startJun 2007
- Primary completionJul 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
- Single blind
- Enrolment
- 24 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
- NCT02171793
- Sponsor's protocol ID
- 1222.19
- 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 Randomised, Single-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Peroral Doses (15, 30, 40 μg Free Cation) BI 1744 CL in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02171793
- Acronym / sponsor ID
- 1222.19
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2007 (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 investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BI 1744 CL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single 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
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- 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 (24 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 |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with abnormal findings in physical examination
Time frame: Baseline, day 17
Number of patients with clinically significant changes in vital signs (blood pressure (BP), pulse rate (PR), respiration rate (RR), oral body temperature)
Time frame: Baseline, up to day 17
Number of patients with clinically relevant abnormal findings in 12-lead electrocardiogram (ECG)
Time frame: Baseline, up to day 17
Number of patients with clinically significant changes in clinical laboratory tests
Time frame: Baseline, up to day 17
Number of patients with Adverse events (AEs)
Time frame: 5 weeks
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 17
13 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after peroral administration)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
CL/F (apparent clearance of the analyte in plasma after peroral administration, will not be calculated for metabolites)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following a peroral dose, will not be calculated for metabolites)
Time frame: pre-dose and 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours after drug administration
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: pre-dose and 0-4, 4-8, 8-12, 12-24, 24-48 h 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 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 4 inclusion and 24 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, day 17). The study lists 6 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.