HealthyPhase 1NCT02216461
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS for HandiHaler® in Healthy Male Volunteers
A Phase 1 study testing Low dose of BIBW 2948 BS for oral inhalation, Medium dose of BIBW 2948 BS for oral inhalation and High dose of BIBW 2948 BS for oral inhalation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated dosing 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?
- Low dose of BIBW 2948 BS for oral inhalation, Medium dose of BIBW 2948 BS for oral inhalation and High dose of BIBW 2948 BS 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
- Jan 2006to Apr 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 males based on a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥21 and Age ≤ 50 years
- BMI (Body Mass Index) ≥18.5 and BMI ≤ 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- Subjects must be current smokers (<10 cigarettes or <3 cigars <3 pipes/day) with a smoking history >1 year
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
- 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 18Show fewer
- History of relevant allergy/hypersensitivity (including allergy to the 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 may have reasonably influenced the results of the trial 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 study centre
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhaled Doses (7.5 to 60 mg Daily for 12 Days) of BIBW 2948 BS Inhalation Powder, Hard Capsule for HandiHaler® in Healthy Male Volunteers (Randomised, Double-blind Placebo-controlled Within Dose Groups)
To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated dosing
- Conditions
- Healthy
- Being tested
- Low dose of BIBW 2948 BS for oral inhalation, Medium dose of BIBW 2948 BS for oral inhalation, High dose of BIBW 2948 BS for oral inhalation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of BIBW 2948 BS for oral inhalationDrug
Medium dose of BIBW 2948 BS for oral inhalationDrug
High dose of BIBW 2948 BS for oral inhalationDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of BIBW 2948 BS | Experimental | Not described Receives: Drug: Low dose of BIBW 2948 BS for oral inhalation |
| Medium dose of BIBW 2948 BS | Experimental | Not described Receives: Drug: Medium dose of BIBW 2948 BS for oral inhalation |
| High dose of BIBW 2948 BS | Experimental | Not described Receives: Drug: High dose of BIBW 2948 BS 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 patients with clinically significant findings in vital signs
Measured: Up to day 20 after start of treatment
Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)
Measured: Up to day 20 after start of treatment
Number of patients with clinically significant findings in clinical laboratory tests
Measured: Up to day 20 after start of treatment
Number of patients with adverse events
Measured: Up to day 41
Assessment of tolerability by investigator on a 4-point scale
Measured: Up to day 20 after start of treatment
Secondary outcomes (19)
Maximum concentration of the analyte BIBW in plasma at different time points (Cmax)
Measured: Pre-dose, up to 336 hours after start of treatment
Time from dosing to maximum measured concentration of the analyte in plasma at different time points (tmax)
Measured: Pre-dose, up to 336 hours after start of treatment
area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ (AUCτ,1)
Measured: Pre-dose, up to 336 hours after start of treatment
The percentage of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUC0-∞) that is obtained by extrapolation (%AUCtz-∞)
Measured: Pre-dose, up to 336 hours after start of treatment
Terminal rate constant of the analyte in plasma at different time points (λz)
Measured: Pre-dose, up to 336 hours after start of treatment
Terminal half-life of the analyte in plasma at different time points (t1/2)
Measured: Pre-dose, up to 336 hours after start of treatment
Mean residence time of the analyte in the body after one administration at different time points (MRTih)
Measured: Pre-dose, up to 336 hours after start of treatment
Apparent clearance of the analyte in plasma following extravascular administration at different time points (CL/F)
Measured: Pre-dose, up to 336 hours after start of treatment
Apparent volume of distribution during the terminal phase λz following an extravascular administration at different time points (Vz/F)
Measured: Pre-dose, up to 336 hours after start of treatment
Amount of analyte that is eliminated in urine from at different time points (Ae)
Measured: Pre-dose, up to 336 hours after start of treatment
Fraction of analyte eliminated in urine at different time points (fe)
Measured: Pre-dose, up to 336 hours after start of treatment
Renal clearance of the analyte at different time points (CLR)
Measured: Pre-dose, up to 336 hours after start of treatment
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: Pre-dose, up to 336 hours after start of treatment
Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ based on Cmax (RA,Cmax,10)
Measured: Pre-dose, up to 336 hours after start of treatment
Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ based on AUC0-τ (RA,AUC,10)
Measured: Pre-dose, up to 336 hours after start of treatment
Linearity index (AUCτ,ss / AUC0-∞)
Measured: Pre-dose, up to 336 hours after start of treatment
Changes from baseline in induced sputum analysis (amount of cells, mucin)
Measured: Pre-dose, 268 hours after start of treatment
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Pre-dose, up to 336 hours after start of treatment
area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz (AUC0-tz)
Measured: Pre-dose, up to 336 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 posted15 Aug 2014 (estimated)
- Study startJan 2006
- Primary completionApr 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
- 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
- NCT02216461
- Sponsor's protocol ID
- 1219.3
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Multiple Rising Inhaled Doses (7.5 to 60 mg Daily for 12 Days) of BIBW 2948 BS Inhalation Powder, Hard Capsule for HandiHaler® in Healthy Male Volunteers (Randomised, Double-blind Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT02216461
- Acronym / sponsor ID
- 1219.3
- 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 2006
- Primary completion
- Apr 2006 (actual)
- First posted
- 15 Aug 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, and pharmacokinetics of BIBW 2948 BS after repeated dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose of BIBW 2948 BS | Experimental | Drug: Low dose of BIBW 2948 BS for oral inhalation |
| Medium dose of BIBW 2948 BS | Experimental | Drug: Medium dose of BIBW 2948 BS for oral inhalation |
| High dose of BIBW 2948 BS | Experimental | Drug: High dose of BIBW 2948 BS for oral inhalation |
| 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 (5 listed)
- Healthy males based on a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Age ≥21 and Age ≤ 50 years
- BMI (Body Mass Index) ≥18.5 and BMI ≤ 29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- Subjects must be current smokers (<10 cigarettes or <3 cigars <3 pipes/day) with a smoking history >1 year
Key exclusion criteria (18 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
- 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 |
|---|---|---|
| Low dose of BIBW 2948 BS for oral inhalation | Drug | Low dose of BIBW 2948 BS |
| Medium dose of BIBW 2948 BS for oral inhalation | Drug | Medium dose of BIBW 2948 BS |
| High dose of BIBW 2948 BS for oral inhalation | Drug | High dose of BIBW 2948 BS |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with clinically significant findings in vital signs
Time frame: Up to day 20 after start of treatment
Number of patients with clinically significant findings in 12-lead electrocardiogram (ECG)
Time frame: Up to day 20 after start of treatment
Number of patients with clinically significant findings in clinical laboratory tests
Time frame: Up to day 20 after start of treatment
Number of patients with adverse events
Time frame: Up to day 41
Assessment of tolerability by investigator on a 4-point scale
Time frame: Up to day 20 after start of treatment
19 secondary outcomes
Maximum concentration of the analyte BIBW in plasma at different time points (Cmax)
Time frame: Pre-dose, up to 336 hours after start of treatment
Time from dosing to maximum measured concentration of the analyte in plasma at different time points (tmax)
Time frame: Pre-dose, up to 336 hours after start of treatment
area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ (AUCτ,1)
Time frame: Pre-dose, up to 336 hours after start of treatment
The percentage of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUC0-∞) that is obtained by extrapolation (%AUCtz-∞)
Time frame: Pre-dose, up to 336 hours after start of treatment
Terminal rate constant of the analyte in plasma at different time points (λz)
Time frame: Pre-dose, up to 336 hours after start of treatment
Terminal half-life of the analyte in plasma at different time points (t1/2)
Time frame: Pre-dose, up to 336 hours after start of treatment
Mean residence time of the analyte in the body after one administration at different time points (MRTih)
Time frame: Pre-dose, up to 336 hours after start of treatment
Apparent clearance of the analyte in plasma following extravascular administration at different time points (CL/F)
Time frame: Pre-dose, up to 336 hours after start of treatment
Apparent volume of distribution during the terminal phase λz following an extravascular administration at different time points (Vz/F)
Time frame: Pre-dose, up to 336 hours after start of treatment
Amount of analyte that is eliminated in urine from at different time points (Ae)
Time frame: Pre-dose, up to 336 hours after start of treatment
Fraction of analyte eliminated in urine at different time points (fe)
Time frame: Pre-dose, up to 336 hours after start of treatment
Renal clearance of the analyte at different time points (CLR)
Time frame: Pre-dose, up to 336 hours after start of treatment
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Pre-dose, up to 336 hours after start of treatment
Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ based on Cmax (RA,Cmax,10)
Time frame: Pre-dose, up to 336 hours after start of treatment
Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ based on AUC0-τ (RA,AUC,10)
Time frame: Pre-dose, up to 336 hours after start of treatment
Linearity index (AUCτ,ss / AUC0-∞)
Time frame: Pre-dose, up to 336 hours after start of treatment
Changes from baseline in induced sputum analysis (amount of cells, mucin)
Time frame: Pre-dose, 268 hours after start of treatment
area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Pre-dose, up to 336 hours after start of treatment
area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz (AUC0-tz)
Time frame: Pre-dose, up to 336 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 15 Aug 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 Low dose of BIBW 2948 BS for oral inhalation, Medium dose of BIBW 2948 BS for oral inhalation and High dose of BIBW 2948 BS 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 5 inclusion and 18 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 15 Aug 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 clinically significant findings in vital signs (time frame: Up to day 20 after start of treatment). The study lists 5 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 15 Aug 2014.