HealthyPhase 1NCT01541488
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
A Phase 1 study testing BI 1021958 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial) 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 1021958
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to May 2012
- 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 relevant deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
- Conditions
- Healthy
- Being tested
- BI 1021958, Placebo to BI 1021958
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1021958Drug
tablet
BI 1021958Drug
drinking solution / tablet
Placebo to BI 1021958Drug
SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| BI 1021958 | Experimental | Single rising dose (SRD) part Receives: Drug: BI 1021958 |
| BI 1021958 (Food effect) | Experimental | Food effect part (FE) Receives: Drug: BI 1021958 |
| Placebo to BI 1021958 | Placebo comparator | Matching placebo as drinking solution and tablets Receives: Drug: Placebo to BI 1021958 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically relevant findings in physical examination
Measured: up to 14 days postdose
Number of participants with clinically relevant findings in vital signs
Measured: up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results
Measured: up to 14 days postdose
Number of participants with significant changes from baseline laboratory measurements
Measured: up to 14 days postdose
Number of participants with adverse events
Measured: up to 14 days postdose
Assessment of tolerability by investigator
Measured: up to 14 days postdose
Secondary outcomes (3)
Cmax (maximum measured concentration of BI 1021958 in plasma)
Measured: up to 72h postdose
area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: up to 72h postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Measured: up to 72h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
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
- Single blind
- Enrolment
- 66 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
- NCT01541488
- Sponsor's protocol ID
- 1310.1
- Other IDs
- 2011-003483-70
- Status last verified
- Oct 2013
- First submitted
- 22 Feb 2012
- Last updated
- 31 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 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 (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)
- ClinicalTrials.gov ID
- NCT01541488
- Acronym / sponsor ID
- 1310.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- First posted
- 1 Mar 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.
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 1021958 | Experimental | Drug: BI 1021958Single rising dose (SRD) part |
| BI 1021958 (Food effect) | Experimental | Drug: BI 1021958Food effect part (FE) |
| Placebo to BI 1021958 | Placebo comparator | Drug: Placebo to BI 1021958Matching placebo as drinking solution and tablets |
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 relevant 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 1021958tablet | Drug | BI 1021958 (Food effect) |
| BI 1021958drinking solution / tablet | Drug | BI 1021958 |
| Placebo to BI 1021958SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast | Drug | Placebo to BI 1021958 |
Primary outcome
Number of participants with clinically relevant findings in physical examination
Time frame: up to 14 days postdose
Number of participants with clinically relevant findings in vital signs
Time frame: up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to 14 days postdose
Number of participants with significant changes from baseline laboratory measurements
Time frame: up to 14 days postdose
Number of participants with adverse events
Time frame: up to 14 days postdose
Assessment of tolerability by investigator
Time frame: up to 14 days postdose
3 secondary outcomes
Cmax (maximum measured concentration of BI 1021958 in plasma)
Time frame: up to 72h postdose
area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: up to 72h postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Time frame: up to 72h postdose
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 31 Oct 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 1021958 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 31 Oct 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 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 of participants with clinically relevant findings in physical examination (time frame: up to 14 days postdose). The study lists 6 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 31 Oct 2013.