HealthyPhase 1NCT01650155
Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.
A Phase 1 study testing BI 1005273 s.c. and BI 1005273 i.v. in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273. 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 1005273 s.c. and BI 1005273 i.v.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Sep 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
- 1. Healthy male subjects
Who cannot join
- 1. Any deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.
- Conditions
- Healthy
- Being tested
- BI 1005273 s.c., BI 105273 i.v. Placebo, BI 1005273 s.c. Placebo, BI 1005273 i.v.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1005273 s.c.Drug
injection
BI 105273 i.v. PlaceboDrug
infusion
BI 1005273 s.c. PlaceboDrug
injection
BI 1005273 i.v.Drug
infusion
| Study group | Role | What they receive |
|---|---|---|
| BI 1005273 i.v. | Experimental | single dose i.v. infusion Receives: Drug: BI 1005273 i.v. |
| BI 1005273 i.v. Placebo | Placebo comparator | single dose i.v. infusion (Placebo) Receives: Drug: BI 105273 i.v. Placebo |
| BI 1005273 s.c. | Experimental | single dose s.c. injection Receives: Drug: BI 1005273 s.c. |
| BI 1005273 s.c. Placebo | Placebo comparator | single dose s.c. injection (Placebo) Receives: Drug: BI 1005273 s.c. Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number (% subjects) with drug-related AEs.
Measured: day -21 to day 95
Secondary outcomes (3)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: day 1 to day 90
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: day 1 to day 90
AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose)
Measured: day 1 to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 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
- Single group
- Masking
- Single blind
- Enrolment
- 88 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
- NCT01650155
- Sponsor's protocol ID
- 1294.1
- Other IDs
- 2011-004987-30
- Status last verified
- Oct 2014
- First submitted
- 18 Jul 2012
- 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, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
- ClinicalTrials.gov ID
- NCT01650155
- Acronym / sponsor ID
- 1294.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Jul 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 the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 1005273 i.v. | Experimental | Drug: BI 1005273 i.v.single dose i.v. infusion |
| BI 1005273 i.v. Placebo | Placebo comparator | Drug: BI 105273 i.v. Placebosingle dose i.v. infusion (Placebo) |
| BI 1005273 s.c. | Experimental | Drug: BI 1005273 s.c.single dose s.c. injection |
| BI 1005273 s.c. Placebo | Placebo comparator | Drug: BI 1005273 s.c. Placebosingle dose s.c. injection (Placebo) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy male subjects
Key exclusion criteria (1 listed)
- 1. Any deviation from healthy conditions
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 1005273 s.c.injection | Drug | BI 1005273 s.c. |
| BI 105273 i.v. Placeboinfusion | Drug | BI 1005273 i.v. Placebo |
| BI 1005273 s.c. Placeboinjection | Drug | BI 1005273 s.c. Placebo |
| BI 1005273 i.v.infusion | Drug | BI 1005273 i.v. |
Primary outcome
number (% subjects) with drug-related AEs.
Time frame: day -21 to day 95
3 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: day 1 to day 90
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: day 1 to day 90
AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose)
Time frame: day 1 to day 90
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
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 1005273 s.c. and BI 1005273 i.v. in people with Healthy, 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 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 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 (% subjects) with drug-related AEs. (time frame: day -21 to day 95). 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.