HealthyPhase 1NCT01917916
Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
A Phase 1 study testing BI 655064 in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.
Trial summary
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers. 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 655064
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 5 Aug 2013to 14 May 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria. Japanese: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan. Chinese: ethnic 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
- Age within the range of 20 to 45 years inclusive
- Body mass index within the range of 18.5 and 25 kg/m2 inclusive
- 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 BP, PR and ECG) deviating from normal and of clinical relevance
- Any disease or clinically relevant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the subject or interfere with the subjects participation in the trial or compromise the trial objectives
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Japan1 site
1293.8.8101 Boehringer Ingelheim Investigational Site
Sumida-ku,Tokyo
South Korea1 site
1293.8.8201 Boehringer Ingelheim Investigational Site
Seoul
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655064 (Buffer Solution for Injection) in Healthy Chinese and Japanese Male Volunteers (Randomised, Double-blind, Placebocontrolled Within Dose Groups, Clinical Phase I Study)
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
- Conditions
- Healthy
- Being tested
- Placebo, BI 655064
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Solution for subcutaneous (s.c.) injection.
BI 655064Drug
Solution for subcutaneous (s.c.) injection.
| Study group | Role | What they receive |
|---|---|---|
| BI 655064 dose group 1 - 80 mg | Experimental | Not described Receives: Drug: BI 655064 |
| BI 655064 dose group 2 - 120 mg | Experimental | Not described Receives: Drug: BI 655064 |
| BI 655064 dose group 3 - 180 mg | Experimental | Not described Receives: Drug: BI 655064 |
| BI 655064 dose group 4 - 240 mg | Experimental | Not described Receives: Drug: BI 655064 |
| Placebo matching BI 655064 | 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 Participants With Investigator Defined Drug-related Adverse Events
Number of participants with investigator defined drug-related adverse events (AEs) is reported.
Measured: From study drug administration until end-of-study examination, up to 77 days.
Secondary outcomes (3)
Maximum Measured Concentration of BI 655064 in Plasma (Cmax)
Maximum measured concentration of BI 655064 in plasma (Cmax) is reported.
Measured: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Measured: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz)
Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported.
Measured: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study start5 Aug 2013
- Primary completion14 May 2014
- Study completion14 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT01917916
- Sponsor's protocol ID
- 1293.8
- Status last verified
- Sep 2022
- First submitted
- 2 Aug 2013
- Last updated
- 9 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655064 (Buffer Solution for Injection) in Healthy Chinese and Japanese Male Volunteers (Randomised, Double-blind, Placebocontrolled Within Dose Groups, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT01917916
- Acronym / sponsor ID
- 1293.8
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2013 (actual)
- Primary completion
- 14 May 2014 (actual)
- Study completion
- 14 May 2014 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Posted 9 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BI 655064 dose group 1 - 80 mg | Experimental | Drug: BI 655064 |
| BI 655064 dose group 2 - 120 mg | Experimental | Drug: BI 655064 |
| BI 655064 dose group 3 - 180 mg | Experimental | Drug: BI 655064 |
| BI 655064 dose group 4 - 240 mg | Experimental | Drug: BI 655064 |
| Placebo matching BI 655064 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria. Japanese: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan. Chinese: ethnic 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
- Age within the range of 20 to 45 years inclusive
- Body mass index within the range of 18.5 and 25 kg/m2 inclusive
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Key exclusion criteria (6 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any disease or clinically relevant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the subject or interfere with the subjects participation in the trial or compromise the trial objectives
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
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 |
|---|---|---|
| PlaceboSolution for subcutaneous (s.c.) injection. | Drug | Placebo matching BI 655064 |
| BI 655064Solution for subcutaneous (s.c.) injection. | Drug | BI 655064 dose group 1 - 80 mg, BI 655064 dose group 2 - 120 mg, BI 655064 dose group 3 - 180 mg, BI 655064 dose group 4 - 240 mg |
Primary outcome
Number of Participants With Investigator Defined Drug-related Adverse Events
Time frame: From study drug administration until end-of-study examination, up to 77 days.
Number of participants with investigator defined drug-related adverse events (AEs) is reported.
3 secondary outcomes
Maximum Measured Concentration of BI 655064 in Plasma (Cmax)
Time frame: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz)
Time frame: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 655064 in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.
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 6 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 9 Aug 2023. 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 Japan, 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?
Yes. Results are posted in the registry (first posted 9 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Investigator Defined Drug-related Adverse Events (time frame: From study drug administration until end-of-study examination, up to 77 days.). 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 9 Aug 2023.