HealthyPhase 1NCT02199860
Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers
A Phase 1 study testing SD I and SD II in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SD I and SD II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Feb 2004
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects could be included in the study if they met the following criteria:
- Healthy male or female volunteers
- Written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation prior to admission to the study
- Age 21 - 50 years
- Body mass index (BMI): 18.5 - 29.9 kg/m2
Who cannot join
- Subjects were not allowed to participate if any of the following applied:
- Any finding of the medical examination (including blood pressure, pulse rate, Respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
- Raw > 3 cm H2O • s • L-1 or FEV1 <80% of predicted
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system, psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts,
Show all 24Show fewer
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged 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 before enrolment in the study
- Use of any drugs which might influence the results of the trial (within 1 week prior to administration of investigational drug or during the trial)
- Participation in another trial with an investigational drug (within 2 months prior to drug administration or during the trial)
- Smoker (>10 cigarettes/day or >3 cigars/day or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (>60 gram/day)
- Drug abuse
- Blood donation (≥100 mL within 4 weeks prior to administration of investigational drug or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range and of clinical relevance
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device
- Inability to maintain this adequate contraception during the whole study period,
- Lactation period
About this study
Official title: A Double-blind (at Each Dose Level), Randomised, Placebo-controlled, Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Two Spray-dried Formulations of BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers
The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. According to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD II with and without concomitant administration of lactose
- Conditions
- Healthy
- Being tested
- SD I, SD II, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD IDrug
SD IIDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SD I - single rising doses | Experimental | Not described Receives: Drug: SD I |
| SD II - single rising doses | Experimental | Not described Receives: Drug: SD II |
| SD II - single rising doses + Placebo | Experimental | Not described Receives: Drug: SD II; Drug: Placebo |
| 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 adverse events
Measured: up to 25 days
Assessment of tolerability on a 4-point scale
Measured: 8 days after drug administration
Change in lung function measurements airway resistance (Raw)
Measured: up to 5 hours after drug administration
Change in lung function measurement specific conductance (SGaw)
Measured: up to 5 hours after drug administration
Change in lunf function measurement forced expiratory volume in 1 second (FEV1)
Measured: up to 5 hours after drug administration
Secondary outcomes (9)
Cmax (Maximum measured concentration of the analyte in plasma)
Measured: up to 48 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 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: up to 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 last quantifiable data point)
Measured: up to 48 hours after drug administration
λz (Terminal rate constant in plasma)
Measured: up to 48 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 48 hours after drug administration
MRTih (Mean residence time of the analyte in the body after inhalation)
Measured: up to 48 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 48 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Measured: up to 48 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 posted25 Jul 2014 (estimated)
- Study startMay 2003
- Primary completionFeb 2004
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
- Single group
- Masking
- Double blind
- Enrolment
- 63 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
- NCT02199860
- Sponsor's protocol ID
- 1149.44
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind (at Each Dose Level), Randomised, Placebo-controlled, Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Two Spray-dried Formulations of BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT02199860
- Acronym / sponsor ID
- 1149.44
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Feb 2004 (actual)
- First posted
- 25 Jul 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.
The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. According to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD II with and without concomitant administration of lactose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SD I - single rising doses | Experimental | Drug: SD I |
| SD II - single rising doses | Experimental | Drug: SD II |
| SD II - single rising doses + Placebo | Experimental | Drug: SD II, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female volunteers
- Written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation prior to admission to the study
- Age 21 - 50 years
- Body mass index (BMI): 18.5 - 29.9 kg/m2
Key exclusion criteria (24 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, Respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
- Raw > 3 cm H2O • s • L-1 or FEV1 <80% of predicted
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system, 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 |
|---|---|---|
| SD I | Drug | SD I - single rising doses |
| SD II | Drug | SD II - single rising doses, SD II - single rising doses + Placebo |
| Placebo | Drug | Placebo, SD II - single rising doses + Placebo |
Primary outcome
Number of patients with adverse events
Time frame: up to 25 days
Assessment of tolerability on a 4-point scale
Time frame: 8 days after drug administration
Change in lung function measurements airway resistance (Raw)
Time frame: up to 5 hours after drug administration
Change in lung function measurement specific conductance (SGaw)
Time frame: up to 5 hours after drug administration
Change in lunf function measurement forced expiratory volume in 1 second (FEV1)
Time frame: up to 5 hours after drug administration
9 secondary outcomes
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 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: up to 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 last quantifiable data point)
Time frame: up to 48 hours after drug administration
λz (Terminal rate constant in plasma)
Time frame: up to 48 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
MRTih (Mean residence time of the analyte in the body after inhalation)
Time frame: up to 48 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 48 hours after drug administration
Vz/F (Apparent volume of distribution of the analyte during the terminal phase)
Time frame: up to 48 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 25 Jul 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 SD I and SD II 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 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 25 Jul 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 adverse events (time frame: up to 25 days). 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 25 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.