HealthyPhase 1NCT02214901
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers
A Phase 1 study testing BIBW 2948 BS for oral inhalation in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS 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?
- 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
- 91 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jul 2005
- 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 physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests:
- No finding deviating from normal and of clinical relevance
- No evidence of a clinically relevant concomitant disease
- Aged between ≥21 and ≤50 years
- BMI (Body Mass Index) between ≥18.5 and ≤30 kg/m2
- Provision of written informed consent signed and dated prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Who cannot join
- Any finding during 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 might reasonably influence 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: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses BIBW 2948 BS (0.75 to 150 mg Inhalation Powder, Hard Capsule for HandiHaler®) in Healthy Male Volunteers
Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS
- Conditions
- Healthy
- Being tested
- 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.
BIBW 2948 BS for oral inhalationDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2948 BS in single rising doses | Experimental | Not described Receives: Drug: 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.
Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature)
Measured: Up to 8 days after start of treatment
Changes from baseline in clinical laboratory tests
Measured: Up to 8 days after start of treatment
Changes from baseline in 12-lead electrocardiogram (ECG)
Measured: Up to 8 days after start of treatment
Number of patients with adverse events
Measured: Up to day 29
Changes from baseline in airway resistance (Raw)
measured via plethysmography
Measured: Pre-dose, up to 24 hours after start of treatment
Assessment of tolerability by investigator, a 4-point scale
Measured: Up to 8 days after start of treatment
Secondary outcomes (12)
Area under the concentration-time curve of the analytes in plasma at different time points (AUCt1-t2)
Measured: Pre-dose, up to 48 hours after start of treatment
Maximum concentration of BIBW 3056 ZW in plasma (Cmax)
Measured: Pre-dose, up to 48 hours after start of treatment
Time from dosing to maximum concentration of the analytes in plasma (tmax)
Measured: Pre-dose, up to 48 hours after start of treatment
Amount of BIBW 3056 ZW eliminated in urine at different time points (Aet1-t2)
Measured: Pre-dose, up to 48 hours after start of treatment
Fraction of BIBW 3065 ZW eliminated in urine at different time points (fet1-t2)
Measured: Pre-dose, up to 48 hours after start of treatment
Renal clearance of BIBW 3056 ZW from 0 to 24 hours (CLR,0-24)
Measured: Pre-dose, up to 48 hours after start of treatment
Terminal rate constant of BIBW 3056 ZW in plasma (λz)
Measured: Pre-dose, up to 48 hours after start of treatment
Terminal half life of BIBW 3056 ZW in plasma (t½)
Measured: Pre-dose, up to 48 hours after start of treatment
Mean residence time of BIBW 3056 ZW in the body after inhalation (MRTih)
Measured: Pre-dose, up to 48 hours after start of treatment
Apparent clearance of BIBW 3056 ZW in the plasma after extravascular administration (CL/F)
Measured: Pre-dose, up to 48 hours after start of treatment
Apparent volume of distribution of BIBW 3056 ZW during the terminal phase λz following an extravascular dose (Vz/F)
Measured: Pre-dose, up to 48 hours after start of treatment
The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
Measured: Pre-dose, up to 48 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 posted13 Aug 2014 (estimated)
- Study startMar 2005
- Primary completionJul 2005
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
- 91 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
- NCT02214901
- Sponsor's protocol ID
- 1219.1
- Status last verified
- Aug 2014
- First submitted
- 12 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 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 Evaluate Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses BIBW 2948 BS (0.75 to 150 mg Inhalation Powder, Hard Capsule for HandiHaler®) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02214901
- Acronym / sponsor ID
- 1219.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jul 2005 (actual)
- First posted
- 13 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.
Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIBW 2948 BS in single rising doses | Experimental | Drug: 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 (6 listed)
- Healthy males based on a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests:
- Aged between ≥21 and ≤50 years
- BMI (Body Mass Index) between ≥18.5 and ≤30 kg/m2
- Provision of written informed consent signed and dated prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Key exclusion criteria (18 listed)
- Any finding during 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 |
|---|---|---|
| BIBW 2948 BS for oral inhalation | Drug | BIBW 2948 BS in single rising doses |
| Placebo | Drug | Placebo |
Primary outcome
Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature)
Time frame: Up to 8 days after start of treatment
Changes from baseline in clinical laboratory tests
Time frame: Up to 8 days after start of treatment
Changes from baseline in 12-lead electrocardiogram (ECG)
Time frame: Up to 8 days after start of treatment
Number of patients with adverse events
Time frame: Up to day 29
Changes from baseline in airway resistance (Raw)
Time frame: Pre-dose, up to 24 hours after start of treatment
measured via plethysmography
Assessment of tolerability by investigator, a 4-point scale
Time frame: Up to 8 days after start of treatment
12 secondary outcomes
Area under the concentration-time curve of the analytes in plasma at different time points (AUCt1-t2)
Time frame: Pre-dose, up to 48 hours after start of treatment
Maximum concentration of BIBW 3056 ZW in plasma (Cmax)
Time frame: Pre-dose, up to 48 hours after start of treatment
Time from dosing to maximum concentration of the analytes in plasma (tmax)
Time frame: Pre-dose, up to 48 hours after start of treatment
Amount of BIBW 3056 ZW eliminated in urine at different time points (Aet1-t2)
Time frame: Pre-dose, up to 48 hours after start of treatment
Fraction of BIBW 3065 ZW eliminated in urine at different time points (fet1-t2)
Time frame: Pre-dose, up to 48 hours after start of treatment
Renal clearance of BIBW 3056 ZW from 0 to 24 hours (CLR,0-24)
Time frame: Pre-dose, up to 48 hours after start of treatment
Terminal rate constant of BIBW 3056 ZW in plasma (λz)
Time frame: Pre-dose, up to 48 hours after start of treatment
Terminal half life of BIBW 3056 ZW in plasma (t½)
Time frame: Pre-dose, up to 48 hours after start of treatment
Mean residence time of BIBW 3056 ZW in the body after inhalation (MRTih)
Time frame: Pre-dose, up to 48 hours after start of treatment
Apparent clearance of BIBW 3056 ZW in the plasma after extravascular administration (CL/F)
Time frame: Pre-dose, up to 48 hours after start of treatment
Apparent volume of distribution of BIBW 3056 ZW during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: Pre-dose, up to 48 hours after start of treatment
The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞)
Time frame: Pre-dose, up to 48 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 13 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 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 6 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 13 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?
Changes from baseline in vital signs (blood pressure, pulse rate, respiratory rate, orthostasis test, oral body temperature) (time frame: Up to 8 days after start of treatment). 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 13 Aug 2014.