HealthyPhase 1NCT01629849
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects
A Phase 1 study testing BI 1021958 bid and BI 1021958 qd in people with Healthy and Asthma, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- BI 1021958 bid and BI 1021958 qd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Dec 2012
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Healthy male and female subjects ofn non child-bearing potential
Who cannot join
- 1. Any relevant deviation from healthy conditions except mild controlled asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 Tablets in Otherwise Healthy Controlled Asthmatic Subjects (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)
To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects
- Being tested
- Placebo to BI 1021958 qd, BI 1021958 bid, Placebo to BI 1021958 bid, BI 1021958 qd
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo to BI 1021958 qdDrug
tablet
BI 1021958 bidDrug
tablets
Placebo to BI 1021958 bidDrug
tablets
BI 1021958 qdDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 1021958 qd | Experimental | Multiple rising dose Receives: Drug: BI 1021958 qd |
| Placebo to BI 1021958 qd | Placebo comparator | Matching placebo as tablets Receives: Drug: Placebo to BI 1021958 qd |
| BI 1021958 bid | Experimental | Multiple rising dose Receives: Drug: BI 1021958 bid |
| Placebo to BI 1021958 bid | Placebo comparator | Matching palcebo as tablet Receives: Drug: Placebo to BI 1021958 bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with drug-related adverse events
Measured: up to day 22
Secondary outcomes (19)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 481:30 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: up to 481:30 h
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Measured: up to 481:30 h
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 within the first dosing interval)
Measured: up to 481:30 h
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 481:30 h
Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered
Measured: up to 481:30 h
terminal rate constant in plasma
Measured: up to 481:30 h
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 481:30 h
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Measured: up to 481:30 h
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Measured: up to 481:30 h
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Measured: up to 481:30 h
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
Measured: up to 481:30 h
terminal rate constant in plasma at steady state
Measured: up to 481:30 h
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: up to 481:30 h
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Measured: up to 481:30 h
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Measured: up to 481:30 h
Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)
Measured: up to 481:30 h
Cavg (average concentration)
Measured: up to 481:30 h
PTF (peak trough fluctuation)
Measured: up to 481:30 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629849
- Sponsor's protocol ID
- 1310.2
- Other IDs
- 2012-000926-23
- Status last verified
- May 2013
- First submitted
- 21 Jun 2012
- Last updated
- 16 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 Tablets in Otherwise Healthy Controlled Asthmatic Subjects (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01629849
- Acronym / sponsor ID
- 1310.2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jun 2012 (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, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 1021958 qd | Experimental | Drug: BI 1021958 qdMultiple rising dose |
| Placebo to BI 1021958 qd | Placebo comparator | Drug: Placebo to BI 1021958 qdMatching placebo as tablets |
| BI 1021958 bid | Experimental | Drug: BI 1021958 bidMultiple rising dose |
| Placebo to BI 1021958 bid | Placebo comparator | Drug: Placebo to BI 1021958 bidMatching palcebo as tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy male and female subjects ofn non child-bearing potential
Key exclusion criteria (1 listed)
- 1. Any relevant deviation from healthy conditions except mild controlled asthma
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 |
|---|---|---|
| Placebo to BI 1021958 qdtablet | Drug | Placebo to BI 1021958 qd |
| BI 1021958 bidtablets | Drug | BI 1021958 bid |
| Placebo to BI 1021958 bidtablets | Drug | Placebo to BI 1021958 bid |
| BI 1021958 qdtablet | Drug | BI 1021958 qd |
Primary outcome
Number of subjects with drug-related adverse events
Time frame: up to day 22
19 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 481:30 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: up to 481:30 h
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Time frame: up to 481:30 h
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 within the first dosing interval)
Time frame: up to 481:30 h
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 481:30 h
Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered
Time frame: up to 481:30 h
terminal rate constant in plasma
Time frame: up to 481:30 h
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 481:30 h
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 481:30 h
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time frame: up to 481:30 h
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 481:30 h
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 481:30 h
terminal rate constant in plasma at steady state
Time frame: up to 481:30 h
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 481:30 h
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: up to 481:30 h
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Time frame: up to 481:30 h
Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)
Time frame: up to 481:30 h
Cavg (average concentration)
Time frame: up to 481:30 h
PTF (peak trough fluctuation)
Time frame: up to 481:30 h
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 16 May 2013.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1021958 bid and BI 1021958 qd in people with Healthy and Asthma, run by Boehringer Ingelheim at 1 site in Germany.
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 1 inclusion and 1 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 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 subjects with drug-related adverse events (time frame: up to day 22). 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 16 May 2013.