HealthyPhase 1NCT02183545
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers
A Phase 1 study testing BI 1060469 in people with Healthy, run by Boehringer Ingelheim at 2 sites in South Korea.
Trial summary
The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1060469
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2014to Oct 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria:
- Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
- Age within the range of 18 to 45 years
- Body mass index within the range of 18.5 and 25 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice(GCP) and local legislation.
Who cannot join
- Any finding in the medical examination (including blood pressure, pulse rate or ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 beat per minute or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Serum creatinine laboratory value outside the normal range
- Glomerular Filtration Rate according to CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Formula < 60 ml/ min
- Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration
- Intake of any NSAIDs(Nonsteroidal anti-inflammatory drugs), COX2(Cyclooxygenase-2) inhibitors, aspirin, ACE(Angiotensin Converting Enzyme) inhibitors, H2-blockers or OTC(Over the Counter Drug)- or nutripharmaceuticals between screening examination and drug administration
- Use of drugs that might reasonably influence the results of the trial (including renal function measurements) or that might prolong the QT/QTc interval within 14 days prior to study drug administration
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 30 g/day)
- Drug abuse or positive drug screen
- Blood donation (more than 100 mL within 30 days prior to administration of trial medication or intended during the trial)
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTc interval greater than 450 ms) or any other relevant ECG finding
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
1333.3.82002 Boehringer Ingelheim Investigational Site
Busan
1333.3.82001 Boehringer Ingelheim Investigational Site
Seoul
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers in a Randomized, Double-blind, Placebo-controlled Design
The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.
- Conditions
- Healthy
- Being tested
- BI 1060469, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1060469Drug
single rising doses given as tablet
PlaceboDrug
given as tablet (matching placebo of BI 1060469)
| Study group | Role | What they receive |
|---|---|---|
| BI 1060469 | Experimental | single rising doses given as tablet Receives: Drug: BI 1060469 |
| Placebo | Placebo comparator | given as tablet (matching placebo of BI 1060469) Receives: Drug: Placebo |
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 14 days after drug administration
Secondary outcomes (3)
Maximum concentration of BI 1060469 (Cmax)
Measured: up to 72 hours after drug administration
Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)
Measured: up to 72 hours after drug administration
Area Under the concentration-time curve of BI 1060469 (AUC0- tz)
Measured: up to 72 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 posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- 80 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
- NCT02183545
- Sponsor's protocol ID
- 1333.3
- Status last verified
- Oct 2014
- First submitted
- 4 Jul 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers in a Randomized, Double-blind, Placebo-controlled Design
- ClinicalTrials.gov ID
- NCT02183545
- Acronym / sponsor ID
- 1333.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 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 this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1060469 | Experimental | Drug: BI 1060469single rising doses given as tablet |
| Placebo | Placebo comparator | Drug: Placebogiven as tablet (matching placebo of BI 1060469) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria:
- Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
- Age within the range of 18 to 45 years
- Body mass index within the range of 18.5 and 25 kg/m2
Key exclusion criteria (25 listed)
- Any finding in the medical examination (including blood pressure, pulse rate or ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 beat per minute or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Serum creatinine laboratory value outside the normal range
- Glomerular Filtration Rate according to CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) Formula < 60 ml/ min
- Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, 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 |
|---|---|---|
| BI 1060469single rising doses given as tablet | Drug | BI 1060469 |
| Placebogiven as tablet (matching placebo of BI 1060469) | Drug | Placebo |
Primary outcome
number of subjects with drug-related adverse events
Time frame: up to 14 days after drug administration
3 secondary outcomes
Maximum concentration of BI 1060469 (Cmax)
Time frame: up to 72 hours after drug administration
Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)
Time frame: up to 72 hours after drug administration
Area Under the concentration-time curve of BI 1060469 (AUC0- tz)
Time frame: up to 72 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 16 Oct 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
2 sites 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 1060469 in people with Healthy, run by Boehringer Ingelheim at 2 sites 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 6 inclusion and 25 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
number of subjects with drug-related adverse events (time frame: up to 14 days after drug administration). 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 Oct 2014.