HealthyPhase 1NCT01291732
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.
A Phase 1 study testing BI 135585 XX in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.
Trial summary
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 135585 XX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2011to Apr 2011
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers,
- Chinese or Japanese ethnicity
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
1283.5.82001 Boehringer Ingelheim Investigational Site
Seoul
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
- Conditions
- Healthy
- Being tested
- Matching placebo, BI 135585 XX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching placeboDrug
single dose of matching placebo
BI 135585 XXDrug
single dose of low, medium or high dose of BI 135585 XX
| Study group | Role | What they receive |
|---|---|---|
| BI 135585 XX | Experimental | single dose of BI 135585 Receives: Drug: BI 135585 XX |
| matching placebo | Placebo comparator | single dose of matching placebo Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
Measured: up to 21 days
Changes in 12-lead ECG (electrocardiogram)
Measured: up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
Measured: up to 21 days
Occurrence of Adverse events
Measured: up to 21 days
Secondary outcomes (3)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 10 days
Tmax (maximum measured concentration of the analyte in plasma)
Measured: 10 days
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
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
- 48 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
- NCT01291732
- Sponsor's protocol ID
- 1283.5
- Status last verified
- Oct 2013
- First submitted
- 7 Feb 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01291732
- Acronym / sponsor ID
- 1283.5
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- First posted
- 8 Feb 2011 (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 Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 135585 XX | Experimental | Drug: BI 135585 XXsingle dose of BI 135585 |
| matching placebo | Placebo comparator | Drug: Matching placebosingle dose of matching placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers,
- Chinese or Japanese ethnicity
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 |
|---|---|---|
| Matching placebosingle dose of matching placebo | Drug | matching placebo |
| BI 135585 XXsingle dose of low, medium or high dose of BI 135585 XX | Drug | BI 135585 XX |
Primary outcome
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
Time frame: up to 21 days
Changes in 12-lead ECG (electrocardiogram)
Time frame: up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
Time frame: up to 21 days
Occurrence of Adverse events
Time frame: up to 21 days
3 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 10 days
Tmax (maximum measured concentration of the analyte in plasma)
Time frame: 10 days
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 10 days
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 1 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 135585 XX in people with Healthy, 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 2 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 1 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?
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR)) (time frame: up to 21 days). 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 1 Nov 2013.