AsthmaPhase 1NCT01216384
Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers
A Phase 1 study testing BI 671800 in people with Asthma and Rhinitis, Allergic, Perennial, run by Boehringer Ingelheim at 1 site in South Korea.
Trial summary
The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma, Rhinitis, Allergic, Perennial
- What is being tested?
- BI 671800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Dec 2010
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
- Age >= 20 and age =< 50
- Body Mass Index (BMI) >=18.5 and BMI =< 25 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Who cannot join
- Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
- Any evidence of a clinically relevant concomitant disease
- Intake of drugs with long half life (>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
Trial locations and contacts
1 site in 1 country.
South Korea1 site
1268.15.8201 Boehringer Ingelheim Investigational Site
Seoul
About this study
Official title: A Randomised, Double-blind (Within Dose Groups), Parallel Group, Placebocontrolled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinese Healthy Male Volunteers and Multiple Rising Doses (50 mg b.i.d., 200 mg b.i.d., 400 mg b.i.d.) of BI 671800 HEA in Japanese Healthy Male Volunteers
The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.
- Conditions
- Asthma, Rhinitis, Allergic, Perennial
- Being tested
- BI 671800, placebo
- Medical subject headings
- Asthma, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 671800Drug
In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
placeboDrug
Subjects will receive according to the dose group matching number of placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| BI 671800 active | Experimental | SRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose. MRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose followed by multiple doses with a PK sampling interval in between. Receives: Drug: BI 671800 |
| Placebo | Placebo comparator | 3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical examination
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Vital signs; Blood Pressure(BP)
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Vital signs; Pulse rate(PR)
Measured: up to 4 days for SRD part and up to 15 days for MRD part
12-lead Electrocardiogram (ECG)
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Hematology)
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Clinical chemistry)
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Urinalysis)
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Adverse events
Measured: up to 4 days for SRD part and up to 15 days for MRD part
Secondary outcomes (39)
SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957
Measured: up to 4 days
SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
Measured: up to 4 days
SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800
Measured: up to 4 days
MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) , BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957
Measured: day1 Visit2, day1 Visit3
MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
Measured: day1 Visit2, day1 Visit3
MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800
Measured: day1 Visit2, day1 Visit 3
MRD Part, Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, BI 671800 and BI 600957
Measured: up to 12 days
MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part, Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part,AUCt1-t2,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time interval t1 to t2) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part,AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957
Measured: up to 12 days
MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957
Measured: up to 12 days
MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957
Measured: up to 12 days
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800
Measured: up to 12 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800
Measured: up to 12 days
Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state
Measured: up to 12 days
Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state
Measured: up to 12 days
Linearity index (LI) of the analyte in plasma
Measured: up to 12 days
AUEC0-24,N absolute inhibition of eosinophil shape change: area under the absolute inhibition of shape change-time curve after the Nth dose of BI 671800 HEA
Measured: up to day 9
AUEC0-24,N percent inhibition of eosinophil shape change: area under the percent inhibition of shape change - time curve after the Nth dose of BI 671800
Measured: up to day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216384
- Sponsor's protocol ID
- 1268.15
- Status last verified
- Nov 2013
- First submitted
- 1 Oct 2010
- Last updated
- 19 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind (Within Dose Groups), Parallel Group, Placebocontrolled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinese Healthy Male Volunteers and Multiple Rising Doses (50 mg b.i.d., 200 mg b.i.d., 400 mg b.i.d.) of BI 671800 HEA in Japanese Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01216384
- Acronym / sponsor ID
- 1268.15
- Conditions
- Asthma, Rhinitis, Allergic, Perennial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 7 Oct 2010 (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 primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 671800 active | Experimental | Drug: BI 671800SRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose. MRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose followed by multiple doses with a PK sampling interval in between. |
| Placebo | Placebo comparator | Drug: placebo3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
- Age >= 20 and age =< 50
- Body Mass Index (BMI) >=18.5 and BMI =< 25 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Key exclusion criteria (3 listed)
- Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
- Any evidence of a clinically relevant concomitant disease
- Intake of drugs with long half life (>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
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 |
|---|---|---|
| BI 671800In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses. | Drug | BI 671800 active |
| placeboSubjects will receive according to the dose group matching number of placebo tablets | Drug | Placebo |
Primary outcome
Physical examination
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
Vital signs; Blood Pressure(BP)
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
Vital signs; Pulse rate(PR)
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
12-lead Electrocardiogram (ECG)
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Hematology)
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Clinical chemistry)
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
Clinical laboratory tests (Urinalysis)
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
Adverse events
Time frame: up to 4 days for SRD part and up to 15 days for MRD part
39 secondary outcomes
SRD Part, Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957
Time frame: up to 4 days
SRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
Time frame: up to 4 days
SRD Part, Vz/F (apparent volume of distribution during the terminal phase λ z following an oral dose); only BI 671800
Time frame: up to 4 days
MRD Part , Cmax (maximum measured concentration of the analyte in plasma) BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, tmax (time from dosing to maximum measured concentration), BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time point t1 to time point t2), BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) , BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, %AUCtz-infinity (the percentage of the AUC 0-infinity that is obtained by extrapolation), BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, λz (terminal rate constant in plasma) ), BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, t1/2 (terminal half-life of the analyte in plasma) BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, MRTpo (mean residence time of the analyte in the body after oral administration) BI 671800 and BI 600957
Time frame: day1 Visit2, day1 Visit3
MRD Part, CL/F (apparent clearance of the analyte in plasma after oral administration); only BI671800
Time frame: day1 Visit2, day1 Visit3
MRD Part, Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose); only BI 671800
Time frame: day1 Visit2, day1 Visit 3
MRD Part, Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part, tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part, Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part,tmin,ss (time from last dosing to minimum concentration of the analyte in plasma at steady state) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part,Cpre,ss (predose concentration of the analyte in plasma immediately before administration of dose at steady state) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part,AUCt1-t2,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time interval t1 to t2) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part,AUC τ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part,λz ,ss (terminal rate constant in plasma at steady state) BI 671800 and BI 600957
Time frame: up to 12 days
MRD Part,t1/2,ss (terminal half-life of the analyte in plasma at steady state) BI 671800 and BI 600957
Time frame: up to 12 days
MRTpo,ss (mean residence time of the analyte in the body at steady state after xx administration) BI 671800 and BI 600957
Time frame: up to 12 days
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration); only BI 671800
Time frame: up to 12 days
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration); only BI 671800
Time frame: up to 12 days
Accumulation ratios RA,Cmax, 13 based on Cmax after the first dose and at steady state
Time frame: up to 12 days
Accumulation ratios RA,AUC,13 based on AUC τ after the first dose and at steady state
Time frame: up to 12 days
Linearity index (LI) of the analyte in plasma
Time frame: up to 12 days
AUEC0-24,N absolute inhibition of eosinophil shape change: area under the absolute inhibition of shape change-time curve after the Nth dose of BI 671800 HEA
Time frame: up to day 9
AUEC0-24,N percent inhibition of eosinophil shape change: area under the percent inhibition of shape change - time curve after the Nth dose of BI 671800
Time frame: up to day 9
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 19 Nov 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 671800 in people with Asthma and Rhinitis, Allergic, Perennial, run by Boehringer Ingelheim at 1 site in South Korea.
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 3 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 19 Nov 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 South Korea. 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?
Physical examination (time frame: up to 4 days for SRD part and up to 15 days for MRD part). The study lists 8 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 19 Nov 2013.