HealthyPhase 1NCT02175238
Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
A Phase 1 study testing BI 691751 fasted and BI 691751 after high fat breakfast in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects. 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 691751 fasted and BI 691751 after high fat breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- 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 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 Electrocardiogramm (ECG), and clinical laboratory tests
- Age 18 to 50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Who cannot join
- Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and 12-lead Electrocardiogramm (ECG)) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- 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
- Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
1334.28.01001 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
About this study
The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.
- Conditions
- Healthy
- Being tested
- BI 691751 fasted, BI 691751 after high fat breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 691751 fastedDrug
single dose BI 691751 in fasted state
BI 691751 after high fat breakfastDrug
single dose BI 691751 after a standardised high fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| BI 691751 after high fat breakfast | Experimental | single dose BI 691751 after a standardised high fat breakfast Receives: Drug: BI 691751 after high fat breakfast |
| BI 691751 fasted | Active comparator | single dose BI 691751 in fasted state Receives: Drug: BI 691751 fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured: up to 480 hours
Maximum measured concentration of the analyte in plasma and whole blood (Cmax)
Measured: up to 480 hours
Secondary outcomes (1)
Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf)
Measured: up to 480 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02175238
- Sponsor's protocol ID
- 1334.28
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02175238
- Acronym / sponsor ID
- 1334.28
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 26 Jun 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 primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 691751 after high fat breakfast | Experimental | Drug: BI 691751 after high fat breakfastsingle dose BI 691751 after a standardised high fat breakfast |
| BI 691751 fasted | Active comparator | Drug: BI 691751 fastedsingle dose BI 691751 in fasted state |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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 Electrocardiogramm (ECG), and clinical laboratory tests
- Age 18 to 50 years (incl.)
- Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Key exclusion criteria (7 listed)
- Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and 12-lead Electrocardiogramm (ECG)) deviating from normal and judged clinically relevant by the investigator
- Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- 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
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 691751 fastedsingle dose BI 691751 in fasted state | Drug | BI 691751 fasted |
| BI 691751 after high fat breakfastsingle dose BI 691751 after a standardised high fat breakfast | Drug | BI 691751 after high fat breakfast |
Primary outcome
Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 480 hours
Maximum measured concentration of the analyte in plasma and whole blood (Cmax)
Time frame: up to 480 hours
1 secondary outcome
Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: up to 480 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 691751 fasted and BI 691751 after high fat breakfast in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 24 Jul 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: up to 480 hours). The study lists 2 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 24 Jul 2014.