HealthyPhase 1NCT02198313
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers
A Phase 1 study testing BIIX 1 XX - D1, BIIX 1 XX - D2 and BIIX 1 XX - D3 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data 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 - D1, BIIX 1 XX - D2 and BIIX 1 XX - D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Apr 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 male volunteers who have Broca-Indices within +-20%
- Participants in the age range between 21 to 50 years
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study. Subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
- Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate or ECG) or laboratory tests deviating form 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 ten 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 the last two months prior to the start of the study
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- History of alcohol abuse and/or 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 Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX (100 µg, 200 µg, 400 µg b.i.d. for 14 Days ) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel-group)
The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
- Conditions
- Healthy
- Being tested
- BIIX 1 XX - D1, BIIX 1 XX - D2, BIIX 1 XX - D3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIX 1 XX - D1Drug
BIIX 1 XX - D2Drug
BIIX 1 XX - D3Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BIIX 1 XX - D1 | Experimental | Not described Receives: Drug: BIIX 1 XX - D1 |
| BIIX 1 XX - D2 | Experimental | Not described Receives: Drug: BIIX 1 XX - D2 |
| BIIX 1 XX - D3 | Experimental | Not described Receives: Drug: BIIX 1 XX - D3 |
| 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 subjects with adverse events
Measured: up to day 28
Number of subjects with abnormal changes in laboratory parameters
Measured: up to day 21
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Measured: up to day 21
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Measured: up to 21 days
Secondary outcomes (6)
AUC (Total Area under the plasma drug concentration time curve)
Measured: up to 336 hours after last drug administration
Cmax (maximum observed concentration of the analyte in plasma)
Measured: up to 336 hours after last drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 336 hours after last drug administration
t½ (Terminal half-life of the analyte in plasma)
Measured: up to 336 hours after last drug administration
MRT (mean time of residence of drug molecules in the body )
Measured: up to 336 hours after last drug administration
CL (Total clearance of the analyte in plasma following extravascular administration)
Measured: up to 336 hours after last 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 startApr 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
- 8 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
- NCT02198313
- Sponsor's protocol ID
- 1150.3
- Status last verified
- Aug 2018
- First submitted
- 22 Jul 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX (100 µg, 200 µg, 400 µg b.i.d. for 14 Days ) in Healthy Male Volunteers (Randomised, Double-blind Within Each Dose Group, Placebo-controlled, Parallel-group)
- ClinicalTrials.gov ID
- NCT02198313
- Acronym / sponsor ID
- 1150.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 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.
The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIIX 1 XX - D1 | Experimental | Drug: BIIX 1 XX - D1 |
| BIIX 1 XX - D2 | Experimental | Drug: BIIX 1 XX - D2 |
| BIIX 1 XX - D3 | Experimental | Drug: BIIX 1 XX - D3 |
| 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 male volunteers who have Broca-Indices within +-20%
- Participants in the age range between 21 to 50 years
- In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study. Subsequently each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
- Haematopoietic, hepatic and renal function test will be carried out in the laboratory
- The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance
Key exclusion criteria (16 listed)
- Any finding of the medical examination (including blood pressure, pulse rate or ECG) or laboratory tests deviating form 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 - D1 | Drug | BIIX 1 XX - D1 |
| BIIX 1 XX - D2 | Drug | BIIX 1 XX - D2 |
| BIIX 1 XX - D3 | Drug | BIIX 1 XX - D3 |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with adverse events
Time frame: up to day 28
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 21
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to day 21
Number of subjects with clinically significant changes in ECG (Electrocardiogram)
Time frame: up to 21 days
6 secondary outcomes
AUC (Total Area under the plasma drug concentration time curve)
Time frame: up to 336 hours after last drug administration
Cmax (maximum observed concentration of the analyte in plasma)
Time frame: up to 336 hours after last drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 336 hours after last drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 336 hours after last drug administration
MRT (mean time of residence of drug molecules in the body )
Time frame: up to 336 hours after last drug administration
CL (Total clearance of the analyte in plasma following extravascular administration)
Time frame: up to 336 hours after last drug administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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 - D1, BIIX 1 XX - D2 and BIIX 1 XX - D3 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 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: stopped early, as of the sponsor's last update on 31 Aug 2018. 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 was stopped early. Results are not available in the source record.
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 subjects with adverse events (time frame: up to day 28). The study lists 4 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 31 Aug 2018.