HealthyPhase 1NCT02198287
Dose Extension Study of BIIX 1 XX in Healthy Young Male Volunteers
A Phase 1 study testing BIIX 1 XX inhalation solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers. 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?
- BIIX 1 XX inhalation solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Apr 1999
- 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 examination
- Age range from 21 to 50 years
- Participant must be within +/- 20 % of their normal weight (Broca-Index)
- Participant must provide written informed consent
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 16Show fewer
- Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than then half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to start of the study
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse
- Drug abuse
- Blood donation (> 100 ml) within four weeks prior to administration
- Other disease or abnormality of clinical relevance
- Excessive physical activities within two weeks prior to administration or during the trial
About this study
Official title: A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- BIIX 1 XX inhalation solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIX 1 XX inhalation solutionDrug
single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIX 1 XX, rising doses | Experimental | Not described Receives: Drug: BIIX 1 XX inhalation solution |
| 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 22 days
Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)
Measured: up to 8 days after drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
Measured: up to 8 days after drug administration
Number of patients with clinically relevant changes in impedance cardiography
Measured: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in cutaneous microcirculation
Measured: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in safety laboratory parameters
Measured: up to 8 days after drug administration
Secondary outcomes (4)
Maximum concentration of the drug in plasma (Cmax)
Measured: up to 168 hours after drug administration
Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)
Measured: up to 168 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 168 hours after drug administration
Clearance, divided by f (CL/f)
Measured: up to 168 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 posted23 Jul 2014 (estimated)
- Study startJan 1999
- Primary completionApr 1999
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
- 54 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
- NCT02198287
- Sponsor's protocol ID
- 1150.7
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Increasing Dose Safety and Tolerability Study (Dose Extension) After Inhalational Administration of BIIX 1 XX (Single Doses: 800 - 2000 mcg) in Healthy Young Male Volunteers (Randomised, Double-blind, Placebo-controlled)
- ClinicalTrials.gov ID
- NCT02198287
- Acronym / sponsor ID
- 1150.7
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Apr 1999 (actual)
- First posted
- 23 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.
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIX 1 XX, rising doses | Experimental | Drug: BIIX 1 XX inhalation solution |
| 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 males, based on a complete medical examination
- Age range from 21 to 50 years
- Participant must be within +/- 20 % of their normal weight (Broca-Index)
- Participant must provide written informed consent
Key exclusion criteria (16 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 |
|---|---|---|
| BIIX 1 XX inhalation solutionsingle doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg | Drug | BIIX 1 XX, rising doses |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events
Time frame: up to 22 days
Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in impedance cardiography
Time frame: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in cutaneous microcirculation
Time frame: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in safety laboratory parameters
Time frame: up to 8 days after drug administration
4 secondary outcomes
Maximum concentration of the drug in plasma (Cmax)
Time frame: up to 168 hours after drug administration
Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)
Time frame: up to 168 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 168 hours after drug administration
Clearance, divided by f (CL/f)
Time frame: up to 168 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 23 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 BIIX 1 XX inhalation solution 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 16 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 23 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 22 days). 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 23 Jul 2014.