HealthyPhase 1NCT02044406
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
A Phase 1 study testing BI 1181181, BI 1181181, R and BI 1181181, T2 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1181181, BI 1181181, R and BI 1181181, T2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
- Age 18 to 50 years (incl.)
- Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening
- Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening
- Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)
- Conditions
- Healthy
- Being tested
- BI 1181181, BI 1181181, R, BI 1181181, T2, Placebo to BI 1181181, BI 1181181, T1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1181181Drug
single dose (low to high dose)
BI 1181181, RDrug
powder for oral solution
BI 1181181, T2Drug
tablet, fasted
Placebo to BI 1181181Drug
Placebo to BI 1181181
BI 1181181, T1Drug
tablet, fed
| Study group | Role | What they receive |
|---|---|---|
| 1 BI 1181181 single rising dose part | Experimental | single rising doses of BI 1181181 Receives: Drug: BI 1181181; Drug: Placebo to BI 1181181 |
| 2 BI 1181181 bioavailability part | Experimental | bioavailability, food effect part of BI 11881181 Receives: Drug: BI 1181181, R; Drug: BI 1181181, T2; Drug: BI 1181181, T1 |
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 (AEs)
Measured: up to 72 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 h
Secondary outcomes (5)
Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)
Measured: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: up to 72 h
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 72 h
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- 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
- 65 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
- NCT02044406
- Sponsor's protocol ID
- 1344.1
- Other IDs
- 2013-002868-88
- Status last verified
- Oct 2014
- First submitted
- 22 Jan 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. 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 of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)
- ClinicalTrials.gov ID
- NCT02044406
- Acronym / sponsor ID
- 1344.1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Jan 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.
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 BI 1181181 single rising dose part | Experimental | Drug: BI 1181181, Drug: Placebo to BI 1181181single rising doses of BI 1181181 |
| 2 BI 1181181 bioavailability part | Experimental | Drug: BI 1181181, R, Drug: BI 1181181, T2, Drug: BI 1181181, T1bioavailability, food effect part of BI 11881181 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
- Age 18 to 50 years (incl.)
- Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Key exclusion criteria (7 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening
- Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening
- Repeated measurement of pulse rate < 50 bpm and > 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
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 1181181single dose (low to high dose) | Drug | 1 BI 1181181 single rising dose part |
| BI 1181181, Rpowder for oral solution | Drug | 2 BI 1181181 bioavailability part |
| BI 1181181, T2tablet, fasted | Drug | 2 BI 1181181 bioavailability part |
| Placebo to BI 1181181Placebo to BI 1181181 | Drug | 1 BI 1181181 single rising dose part |
| BI 1181181, T1tablet, fed | Drug | 2 BI 1181181 bioavailability part |
Primary outcome
Number (%) of subjects with drug-related adverse events (AEs)
Time frame: up to 72 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
5 secondary outcomes
Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)
Time frame: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 h
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 h
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 8 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 1181181, BI 1181181, R and BI 1181181, T2 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 4 inclusion and 7 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 8 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. 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 (AEs) (time frame: up to 72 h). The study lists 3 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 8 Oct 2014.